Inspections, Compliance, Enforcement, and Criminal Investigations
|
|
- Tabitha Patrick
- 6 years ago
- Views:
Transcription
1 Page 1 of 6 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Keystone Laboratories Inc 3/18/13 Department of Health and Human Services Public Health Service Food and Drug Administration New Orleans District 404 BNA Drive Building 200, Suite 500 Nashville, TN Telephone: Facsimile: March 18, 2013 WARNING LETTER NO NOL-08 UNITED PARCEL SERVICE DELIVERY SIGNATURE REQUESTED Melinda Menke Burns, Owner Keystone Laboratories, Inc. 950 Martinez Springs Road Bozeman, Montana Dear Ms. Burns: During our August 15, 16, 20, 21, 23, and 29, 2012, inspection of your pharmaceutical manufacturing facility, Keystone Laboratories, Inc. located at 1103 Kansas Street, Memphis Tennessee, an investigator from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 & 211). These violations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 351(a)(2)(B)] as the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP. In addition to the CGMP violations, your firm manufactures numerous products that are presented as cosmetics. Based on the labeling, such products are drugs as defined by Section 201(g)(1) of the Act [21 USC 321(g)(1)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man. As presently formulated, labeled, and promoted, these products are unapproved and/or misbranded drugs in violation of Sections 301(d), 505(a), 502(f)(2), 502(c), and 502(e)(1)(A)(ii) of the Act [21 USC 331(d), 355(a), 352(c), and 552(e)(1)(A)(ii)] as further described below. Please note this is not inclusive of all the products your firm manufactures and/or distributes and may not represent all product violations. Our inspection also revealed your firm failed to fulfill its registration obligations under Section
2 Page 2 of 6 510(i)(1) of the Act and its listing obligations under Section 510(i)(2) and 510(j) [21 USC 360 (i)(1), 360(i)(2), and 360(j)]. As a result, your drugs are misbranded under Section 502(o) of the Act [21 USC 352(o)]. You may find regulations through links on FDA s Internet home page at 1. Our investigator observed specific violations during the inspection of your facility, which produces over-the-counter (OTC) topical drug products, including, but not limited to, the following: CGMP Violations 1. Your firm failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (21 CFR ). For example, our investigator observed condensate leaking into a bucket that was secured to the ceiling over the production area, and peeling paint on the floors, walls and support beams in the production area. This is a repeat observation from our 2009 and 2011 inspections. 2. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR ). For example, your firm utilizes wooden sticks in processing and cardboard covers on production equipment. These wooden sticks come into contact with your drug products and the cardboard is used on equipment to cover open product during processing. These materials (wood and cardboard) are not appropriate for drug manufacturing their construction makes them difficult or impossible to clean and can therefore become a source of microbial contaminants, dirt, and residues of other drugs that may alter your product s quality. 3. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements [21 CFR (a)]. Our investigator observed the following examples: a) Deep scratches and rust like stains in vessels used to measure and mix drug products. Equipment used in drug product manufacturing must have smooth surfaces which facilitate cleaning to prevent product contamination b) Equipment and utensils with visible build up and filth and lack of documentation to indicate that equipment was cleaned at appropriate intervals to prevent contamination This is a repeat observation from our 2009 and 2011 inspections. 4. Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate and released for use by the quality control unit [21 CFR (a) and (d)(6)]. For example, the water you use in your drug products is a component with the potential for microbiological contamination which is objectionable in view of the component s intended use. Notwithstanding this, your firm failed to subject the water to routine microbiological testing. Furthermore, your firm failed to validate the water system to ensure consistent water quality for drug production and implement procedures for maintaining or monitoring the quality of the water produced. You can determine the
3 Page 3 of 6 frequency of water testing based upon the intended use of the product and other considerations. This is a repeat observation from our 2011 inspection. 5. Your firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to document same at the time of performance, and to record and justify any deviations from them [21 CFR (b)]. Specifically, records for released product routinely required, but lacked the secondary verification of significant steps in the operation, such as verification of component weights dispensed. Violative Over-the-Counter (OTC) Drug Products Long Aid Medicated Hair Revitalizer Anti-Itch Formula The package labeling for the Long Aid Medicated Hair Revitalizer Anti-Itch Formula identifies Salicylic Acid as the active ingredient and based on information on its label the product is intended for the control of dandruff and microbial growth. The dandruff indication is addressed under 21 CFR 358 Subpart H Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis. Therefore, this product is a drug as defined by Section 20l(g)(l) of the Act [21 USC 321(g)(l)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man. However, Long Aid Medicated Hair Revitalizer Anti-Itch Formula is not labeled in conformance with the final monograph. In particular, the antibacterial indication for Long Aid Medicated Hair Revitalizer Anti-Itch Formula is not included as an indication for use in the OTC Final Monograph for Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis. For this reason, Long Aid Medicated Hair Revitalizer Anti-Itch Formula is a new drug under Section 201(p) of the Act [21 USC 321(p)] and may not be legally marketed in the United States without approved applications under Section 505(a) of the Act [21 USC 355(a)]. Since the product is not the subject of an approved new drug application, its marketing in the United States violates Sections 301(d) and 505(a) of the Act [21 USC 331(d) and 355(a)]. Furthermore, Long Aid Medicated Hair Revitalizer Anti-Itch Formula products are misbranded under Section 502(c) of the Act [21 USC 352(c)], because the product is not labeled in accordance with the Drug Facts labeling requirements described in 21 CFR Long Aid Medicated Hair Revitalizer Anti-Itch Formula is also misbranded under Section 502(f) (2) of the Act [21 USC 352(f)(2)] because the product fails to bear required warnings per 21 CFR (c). For instance, its labeling must include the statement: For external use only. ULTRA GLOW Fade Creams The package labeling for your ULTRA GLOW Fade Creams identifies Hydroquinone 2% and Padimate O 1.5%as active ingredients. The labeled uses for these products include fades skin discolorations by lightening dark spots such as freckles, age spots, and blemishes. Based on the labeling described above, your ULTRA GLOW Fade Creams are drugs as defined by Section 20l(g)(l) of the Act [21 USC 321(g)(l)] because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man. Based on the product s labeled indications for use, the products intended use is addressed under the Proposed Rule for Miscellaneous External Drug Products for Over-the- Counter Human Use Subpart A Skin Bleaching Drug Products (71 FR 39108, September 3, 1982). As a skin bleaching OTC drug, your product must either be addressed by the ongoing OTC rulemaking for skin bleaching products, be eligible for inclusion in the OTC rulemaking, or have an FDA approved application in order to be legally marketed. Furthermore, such marketing
4 Page 4 of 6 under ongoing rulemaking is subject to the rulemaking becoming final and may result in you having to reformulate your product. Furthermore, as OTC drugs your products must also meet general OTC drug labeling requirements. However, your ULTRA GLOW Fade Creams are misbranded under Section 502(c) of the Act [21 USC 352(c)], because the products are not labeled in accordance with the Drug Facts labeling requirements described in 21 CFR Your ULTRA GLOW skin care products are also misbranded under Section 502(c) of the Act [21 USC 352(c)] because their labeling includes both English and French but some of the information required under authority of the Act appears only in English and not in French. For example, the labels include a list of inactive ingredients in the English language as required under Section 502(e)(1)(A)(iii) of the Act [352 USC (e)(1)(a)(iii) ] but lacks a complete list of inactive ingredients in the French language. Under 21 CFR (c)(2) and (c)(3) if a product s label or labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label shall appear thereon in the foreign language. BETTER BRAIDS Hair Care Products medicated BETTER BRAIDS Shampoo medicated BETTER BRAIDS Leave-in-Conditioner medicated BETTER BRAIDS Un-Braid medicated BETTER BRAIDS Spray The package labeling for the products mentioned above identifies Salicylic Acid as the active ingredient and based on information on their labels or their labeling at these products are medicated and intended for the control of dandruff or psoriasis. Such indications are addressed under 21 CFR 358 Subpart H Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis. In accordance with this Final Rule, your products mentioned above are drugs, as defined by Section 20l(g)(l) of the Act [21 USC 321(g) (l)] because they are intended to affect the structure or function of the body of man. In addition, in order to be legally marketed for control of dandruff or psoriasis without an FDA approved application, your products must conform to the requirements set forth under the final monograph noted above. Absent conforming to the conditions of the final monograph your products would be considered new drugs under Section 201(p) of the Act [21 USC 321 (p)] and without an approved application, unapproved new drugs under Sections 301(d) and 505(a) of the Act [21 USC 331(d) and 355(a)], may not be introduced or delivered for introduction into interstate commerce. Furthermore, as OTC drugs your products must meet general OTC drug labeling requirements. However, BETTER BRAIDS products are misbranded under Section 502(f)(2) of the Act [21 USC 352(f)(2)] because they fail to bear required warnings per 21 CFR (c). For instance, their labeling must include the statement: For external use only. Further, your BETTER BRAIDS products are misbranded under Section 502(e)(1)(A)(ii) of the Act [21 USC 352(e)(1)(A)(ii)] because their labeling fails include the percentage of Salicylic Acid. The acceptable range, listed in 21 CFR (a), is 1.8 to 3 percent. Your BETTER BRAIDS products are also misbranded under Section 502(c) of the Act [21 USC 352(c)], because the products are not labeled in accordance with the Drug Facts labeling requirements described in 21 CFR Your BETTER BRAIDS products are also misbranded under Section 502(c) of the Act [21 USC 352(c)] because their labeling includes both English and French but some of the information required under authority of the Act appears only in English and not in French. As an example, the labels include a list of inactive ingredients in the English language as required under Section 502(e)(1)(A)(iii) of the Act [352 USC (e)(1)(a)(iii) ] but lacks a complete list of all inactive ingredients in the French language. Under 21 CFR (c)(2) and (3) if a product s label or
5 Page 5 of 6 labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label shall appear thereon in the foreign language. Drug Registration and Listing Violations Additionally, under Section 510 of the Act [21 USC 360], manufacturers of drug products are required to annually register with the FDA. Our records indicate your firm has failed to fulfill its registration obligations. Because of this, all drug products you prepare are misbranded as they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510 of the Act [21 USC 360], and the products have not been listed, as required by Section 510(j) of the Act [21 USC 360(j)]. You were given prior notice of this by letter dated November 2, 2011, after our inspection during June 2011, during which your firm committed to update your registration with the FDA. The violations cited in this letter are not intended to be an all-inclusive list of violations existing at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. Repeat citations from prior inspections indicate your quality control unit is not exercising its responsibilities, and may not have the appropriate authority to carry out its responsibilities. Due to continuing CGMP issues at your firm, we recommend you engage a third party consultant with appropriate CGMP expertise to assess your firm s facility, procedures, processes, and systems to ensure the drugs you manufacture have their appropriate identity, strength, quality, and purity. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Other federal agencies may take this warning letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed. Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct and prevent the recurrence of violations, and provide copies of supporting documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the date by which you will have completed the corrections. Additionally, if you no longer manufacture or distribute the drug products at issue, provide the date(s) and reason(s) you ceased production. Please address all correspondence to Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Asente at (504) , extension Sincerely, /S/ Patricia K. Schafer District Director New Orleans District cc: Bonnie L. Culp General Manager and Comptroller Keystone Laboratories, Inc Kansas Street Memphis, Tennessee Page Last Updated: 03/21/2013
6 Page 6 of 6 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD Ph INFO-FDA ( ) FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page: 1.
Jaychem Industries Ltd 9/4/15
Jaychem Industries Ltd 9/4/15 Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring, MD 20993 VIA UPS RETURN RECEIPT REQUESTED Warning Letter WL: 320-15-16
More informationREGISTRATIONS APPROVALS LISTINGS PREPARING FOR US FDA INSPECTIONS 483 RESPONSES
REGISTRATIONS APPROVALS LISTINGS PREPARING FOR US FDA INSPECTIONS 483 RESPONSES FORMULATIONS & API s MEDICAL DEVICES FOOD FEED DIETARY SUPPLIMENTS COSMETICS United States Agent Services Under the Code
More informationH 7915 S T A T E O F R H O D E I S L A N D
LC00 0 -- H S T A T E O F R H O D E I S L A N D IN GENERAL ASSEMBLY JANUARY SESSION, A.D. 0 A N A C T RELATING TO FOOD AND DRUGS - RHODE ISLAND FOOD, DRUGS, AND COSMETICS ACT Introduced By: Representatives
More informationFDA Update. What s New? FDA Reorganization 9/13/2012. FDA Reorganization Role of Third Parties in Ensuring Supply Chain Integrity
FDA Update Karyn M. Campbell, Director Investigations Branch US Food and Drug Administration Philadelphia District Office What s New? Role of Third Parties in Ensuring Supply Chain Integrity Office of
More informationUniversity of Wisconsin-Madison Hazard Communication Standard Policy Dept. of Environment, Health & Safety Office of Chemical Safety
University of Wisconsin-Madison Hazard Communication Standard Policy Dept. of Environment, Health & Safety Office of Chemical Safety 1.0 Introduction... 1 1.1 Purpose... 1 1.2 Regulatory Background...
More informationCHAPTER Committee Substitute for House Bill No. 729
CHAPTER 2010-220 Committee Substitute for House Bill No. 729 An act relating to the practice of tattooing; creating s. 381.00771, F.S.; defining terms; creating s. 381.00773, F.S.; exempting certain personnel
More informationSeptember 23, Dear Dr. Hamburg:
September 23, 2011 Dr. Margaret A. Hamburg, M.D. Commissioner of Food and Drugs U.S. Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Dear Dr. Hamburg: On behalf of the
More informationCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE National Drug Code Directory
68682-132-50 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE National Drug Code Directory The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA)
More informationMorningside College. Written Program. for. Hazard Communication
Morningside College Written Program for Hazard Communication 1910.1200 Hazard Communication Program Table of Contents I. Objective II. Assignment of Responsibility III. Program A. Hazardous Chemical List
More informationKoC03of. 510(k) SUMMARY. Lexington International, LLC LaserComb. Submitter's Contact Information. Name: David Michaels, Managing Director JAN
KoC03of 510(k) SUMMARY Lexington International, LLC LaserComb Submitter's Contact Information Name: David Michaels, Managing Director JAN 1 8 2667 Address: Lexington International, LLC 2650 North Military
More informationSANITARY REQUIREMENTS FOR TATTOO & BODY PIERCING ESTABLISHMENTS
SANITARY REQUIREMENTS FOR TATTOO & BODY PIERCING ESTABLISHMENTS A REGULATION OF THE BOARD OF HEALTH OF THE MAHONING COUNTY GENERAL HEALTH DISTRICT ESTABLISHING REGISTRATION REQUIREMENTS FOR TATTOO & BODY
More informationBelow is the indication and summary of the most serious and most common risks associated with the use of Natroba. 1
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Kerry W. Mettert Director, Quality and Regulatory 11550 North Meridian
More informationAccording to the INDICATIONS AND USAGE section of its FDA-approved product labeling (PI) (emphasis in original):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Bhavana Desai Senior Director, Advertising and Promotional Compliance
More informationTHE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL
PRIOR PRINTER'S NOS., PRINTER'S NO. THE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL No. Session of 0 INTRODUCED BY R. BROWN, BOBACK, CALTAGIRONE, COHEN, DAY, DEASY, DONATUCCI, FRANKEL, HARKINS, HEFFLEY,
More informationNew Mexico Institute of Mining & Technology. Hazard Communication Policy
New Mexico Institute of Mining & Technology Hazard Communication Policy BASIS: The OSHA Hazard Communication Standard establishes uniform requirements to ensure that the hazards of all chemicals used at
More informationPR BENZOYL PEROXIDE WASH National Drug Code Directory
42546-145-16 PR BENZOYL PEROXIDE WASH National Drug Code Directory The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current
More informationLICENSE REQUIRED FOR TATTOO ESTABLISHMENT AND/OR BODY PIERCING ESTABLISHMENT.
Tattoo/Body Piercing Business License City Ordinance provides for licensing of businesses engaged in providing tattoos. Please review the complete City Ordinance on Tattooing in Section 115. 115.02 LICENSE
More informationCCS Administrative Procedure T Biosafety for Laboratory Settings
CCS Administrative Procedure 2.30.05-T Biosafety for Laboratory Settings Implementing Board Policy 2.30.05 Contact: College Biosafety Hygiene Officers, (phone # to be determined) 1.0 Purpose Community
More informationHazard. Communication 29 CFR
Sample Written Program For Your Company Hazard Communication 29 CFR 1900.1210 Provided By: P.O. Box 2136 Slidell, LA 70458 Phone: 985-781-1444 Fax: 985-718-4957 Email: info@se-safety.com 29 CFR 1910.1200
More informationSANITARY REQUIREMENTS FOR TATTOO & BODY PIERCING ESTABLISHMENTS
SANITARY REQUIREMENTS FOR TATTOO & BODY PIERCING ESTABLISHMENTS A REGULATION OF THE BOARD OF HEALTH OF THE MAHONING COUNTY GENERAL HEALTH DISTRICT ESTABLISHING REGISTRATION REQUIREMENTS FOR TATTOO & BODY
More informationUNIVERSITY OF HAWAII Community Colleges ENVIRONMENTAL HEALTH AND SAFETY OFFICE HAZARD COMMUNICATION PROGRAM
UNIVERSITY OF HAWAII Community Colleges ENVIRONMENTAL HEALTH AND SAFETY OFFICE HAZARD COMMUNICATION PROGRAM Revised January 2011 TABLE OF CONTENTS 1.0 INTRODUCTION 2.0 PROGRAM ADMINISTRATION 3.0 AN OVERVIEW
More informationSpring 2005 Pollution Prevention Workshop For Healthcare
Spring 2005 Pollution Prevention Workshop For Healthcare Regulated Medical Waste Compliance Issues Daniel Salzler ADEQ Solid Waste Inspection & Compliance Unit Arizona Solid Waste Rules Arizona Administrative
More informationCOSMETICS REFORM EXPLAINED
COSMETICS REFORM EXPLAINED 2 BACKGROUND/ INTRO 3 Background/Intro At the Johnson & Johnson & Johnson Family of Consumer Companies, we recognize that consumer confidence is more than a formula, which is
More informationWeber State University Hazard Communication Program April 2000
Weber State University Hazard Communication Program April 2000 CONTENTS I. Introduction II Listing of Hazardous Materials III. Material Safety Data Sheets IV. Labels and Other Forms of Warning V. Employee
More informationSociety of Cosmetic Chemists. Robert Ross-Fichtner SCC Toronto April 6, 2016
Society of Cosmetic Chemists Toronto Chapter Robert Ross-Fichtner SCC Toronto April 6, 2016 1 Let s see what we will do in the next hour Sessions Bill The Safe CosmeticsModernization Act Feinstein Collins
More informationUnited States Standards for Grades of Cucumbers
Marketing and Regulatory Programs Agricultural Marketing Service Specialty Crops Program Specialty Crops Inspection Division United States Standards for Grades of Cucumbers Effective September 6, 2016
More informationCosmetic Defined in FD&C Act, Section 201 (i) Articles intended for: Cleansing Beautifying Promoting attractiveness Altering the appearance Excludes S
Cosmetics and Color Additives Personal Care Product Council GMP Workshop November 10, 2010 Presented by Richard Chiang Compliance Manager FDA Los Angeles Import Operations Cosmetics Scope Used by most
More informationHAZARD COMMUNICATION PROGRAM
HAZARD COMMUNICATION PROGRAM I. Purpose In order to protect our employees and comply with 29 CFR 1910.1200 the Hazard Communication Standard, the following written Hazard Communication Program has been
More informationSUTTER COUNTY DEVELOPMENT SERVICES DEPARTMENT
SUTTER COUNTY DEVELOPMENT SERVICES DEPARTMENT Building Inspection Planning Fire Services Road Maintenance Code Enforcement Environmental Health Engineering Water Resources SUMMARY OF THE SAFE BODY ART
More informationGENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2001 H 1 HOUSE BILL 635. March 15, 2001
GENERAL ASSEMBLY OF NORTH CAROLINA SESSION 00 H HOUSE BILL Short Title: Regulate Body Piercing. Sponsors: Representatives Mitchell; Capps and Setzer. Referred to: Finance. (Public) March, 00 0 A BILL TO
More informationDECON-HAND. Instant Hand Sanitizer. HAND_VL Revised 19 November, Technical Data File
Instant Hand Sanitizer HAND_VL-1401-3 Revised 19 November, 2013 Technical Data File, USA T: 610.644.8335 F: 610.644.8336 www.sterile.com 1 of 7 PRODUCT DESCRIPTION VAI manufactures an alcohol-based hand
More informationPLEASE NOTE: ADDITIONAL DOCUMENTATION ON PAGE 2 MUST BE SUBMITTED WITH THIS APPLICATION. Name Business is Conducted Under (DBA):
BUSINESS FILING AND VERIFICATION SECTION TATTOO STUDIO Initial / Renewal License Application (Health and Safety Code, Chapter 146 Return both the completed application, and nonrefundable check or money
More informationRULES GOVERNING BODY PIERCING TATTOO ESTABLISHMENTS
NEW HANOVER COUNTY BOARD OF HEALTH RULES GOVERNING BODY PIERCING And TATTOO ESTABLISHMENTS In NEW HANOVER COUNTY NORTH CAROLINA EFFECTIVE NOVEMBER 8, 1995 Amended March 7, 2018 11/08/95 03/07/18 History
More informationHouse Bill 2587 Sponsored by Representative BARNHART (Presession filed.)
th OREGON LEGISLATIVE ASSEMBLY--0 Regular Session House Bill Sponsored by Representative BARNHART (Presession filed.) SUMMARY The following summary is not prepared by the sponsors of the measure and is
More informationHEALTH QUALITY ENVIRONMENT SERVICE INNOVATION CSR INDUSTRY 4.0 CONTRACT MANUFACTURING
HEALTH QUALITY ENVIRONMENT SERVICE INNOVATION CSR INDUSTRY 4.0 CONTRACT MANUFACTURING We take care of your product under your specifications. Quality, flexibility and a spirit of service are our arguments.
More informationDefinition of Cosmetic(I)
1 Definition of Cosmetic(I) COSMETIC Any item intended to be used by means of spreading, rubbing, spraying on or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness
More information[Second Reprint] ASSEMBLY, No STATE OF NEW JERSEY. 218th LEGISLATURE INTRODUCED FEBRUARY 8, 2018
[Second Reprint] ASSEMBLY, No. 0 STATE OF NEW JERSEY th LEGISLATURE INTRODUCED FEBRUARY, 0 Sponsored by: Assemblywoman VALERIE VAINIERI HUTTLE District (Bergen) Assemblywoman ANGELICA M. JIMENEZ District
More informationFDA ISSUES 12/19/2012 SPECIFIC PROMOTIONAL PRODUCTS ISSUES
FDA ISSUES How To Stay on the Sweet Side of the Law; FDA Issues that affect the Promotional Products Industry SPECIFIC PROMOTIONAL PRODUCTS ISSUES FOOD (including confectionaries, i.e. candy, gum, mints,
More informationStrengthening the Compliance to the Malaysia Cosmetic Regulation & Requirements
Strengthening the Compliance to the Malaysia Cosmetic Regulation & Requirements 1 Presentation Outline Introduction Post Market Surveillance : Challenges New updates : directives, circular & guidelines
More informationWe understand that a competitor has raised the following issues which we will address in this letter.
March 01, 2010 Dear Customer, Thank you for your recent inquiry into PURELL Waterless Surgical Scrub. PURELL is an effective surgical scrub formulation that meets the requirements of the surgical scrub
More informationOHIO UNIVERSITY HAZARD COMMUNICATION PROGRAM (FOR NON-LABORATORY APPLICATIONS) Dept. Name Today s Date Dept. Hazard Communication Contact
OHIO UNIVERSITY HAZARD COMMUNICATION PROGRAM (FOR NON-LABORATORY APPLICATIONS) Dept. Name Today s Date Dept. Hazard Communication Contact rev. 01/09/07 INDEX SCOPE 3 PURPOSE 3 REFERENCES 3 DEFINITIONS
More informationQueen's University Technicians Position Description Questionnaire. Immediate Supervisor: Manager, Biohazard, Radiation and Chemical Safety
Queen's University Technicians Position Description Questionnaire Field of Work: Safety Technician (Biohazard and Chemical Safety) Name: TBA Department: Environmental Health & Safety Date: June 22, 2018
More information2-12 MANUAL OF NAVAL PREVENTIVE MEDICINE 2-15 evaluation is not routinely required. The local medical officer may delegate this responsibility to non-physician civilian or military personnel, e.g., environmental
More informationGUIDELINES FOR THE IMPLEMENTATION AND ENFORCEMENT OF BOSTON PUBLIC HEALTH COMMISSION S BODY ART REGULATIONS
GUIDELINES FOR THE IMPLEMENTATION AND ENFORCEMENT OF BOSTON PUBLIC HEALTH COMMISSION S BODY ART REGULATIONS APPROVED: Introduction Monica Valdes Lupi Executive Director Revised: September 19, 2017 The
More informationA Bill Regular Session, 2007 SENATE BILL 276
Stricken language would be deleted from and underlined language would be added to the law as it existed prior to this session of the General Assembly. Act 0 of the Regular Session State of Arkansas th
More informationLatest Regulation changes in Asia
Latest Regulation changes in Asia 1 Alain Khaiat, Ph. D. President Seers Consulting Lifetime Achievement Award in-cosmetics, Paris 2010 3 ASEAN Country Population GDP/capita (World Bank ) in $ Brunei
More informationBODY ART FACILITY PLAN REVIEW OVERVIEW
BODY ART FACILITY PLAN REVIEW OVERVIEW The City of Pasadena Public Health Department, Environmental Health Division shall issue a health permit for a body art facility after an investigation has determined
More informationIt is unlawful to operate a tattoo shop or establishment without first obtaining a license as required by this chapter.
5.70.010 - License required. 5.70.020 - Requirements for building or operator. 5.70.030 - Tattooing procedure regulations. 5.70.040 - Health-related requirements. 5.70.050 - Recordkeeping. 5.70.060 - Unlawful
More informationEASTERN KENTUCKY UNIVERSITY HAZARD COMMUNICATION PROGRAM SUMMARY COMPLIANCE MANUAL. Table of Contents
EASTERN KENTUCKY UNIVERSITY HAZARD COMMUNICATION PROGRAM SUMMARY COMPLIANCE MANUAL Table of Contents I. OVERVIEW OF THE HAZARD COMMUNICATION STANDARD A. Background and Scope.................................
More informationRevised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter
4160-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 201 [Docket No. FDA-1978-N-0018] (formerly Docket No. 1978N-0038) RIN 0910-AF43 Revised Effectiveness Determination;
More informationRESEARCH PERMIT SIGN-OFF SHEET. The attached research application has been reviewed by the individuals below with recommendations as follows:
RESEARCH PERMIT SIGN-OFF SHEET Name of Research Project Representative: Project Representative Address & Phone Project Funder: The attached research application has been reviewed by the individuals below
More information2:08-cv PMD-GCK Date Filed 02/05/2008 Entry Number 1 Page 1 of 11
2:08-cv-00404-PMD-GCK Date Filed 02/05/2008 Entry Number 1 Page 1 of 11 THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF SOUTH CAROLINA CHARLESTON DIVISION CHANEL, INC., a New York Corporation, CASE
More informationThe 17 th Western China International Fair 2018
REGULATIONS AND COMMITMENTS FOR THE PARTICIPATION IN THE PROMOTIONAL INITIATIVES ORGANIZED BY THE FONDAZIONE PROGETTO ITALIA-CINA(AGENZIA PER LA PROMOZIONE INVESTIMENTI DEL SICHUAN IN ITALIA(SVIZZERA)
More informationwww k. b o d opro ucts.com
SFDA was established in 1998 > a regulatory agency directly under the State Council, > supervises food, health care products, cosmetics safety management and competent drug. > responsible for the administrative
More informationGermanna Community College Policy 70210: Hazard Communication Plan
1. Purpose Germanna Community College Policy 70210: Hazard Communication Plan 1.1. To establish guidelines and policies to make Germanna Community College employees aware of chemical hazards to which they
More informationTATTOOIST AND BODY PIERCING
TATTOOIST AND BODY PIERCING INSTRUCTIONS TO APPLICANTS A. LICENSE BY EXPERIENCE: Applicants must submit the following: 1. Complete Application 2. Application Fee of $75.00 (n-refundable Processing Fee)
More informationWritten Program. for. Hazard Communication
Written Program for Hazard Communication 1910.1200 Hazard Communication The following hazard communication program is provided as a guide to assist employers and employees in complying with the requirements
More informationEvaluation of Cosmeceutical Ingredients: What the Label May Not Reveal Patrick Bitter, MD. Regulation of Topical Skin Care Products.
Evaluation of Cosmeceutical Ingredients: What the Label May Not Reveal Patrick Bitter, MD Regulation of Topical Skin Care Products US Food and Drug Administration (FDA) recognizes two categories of products
More informationRegulation of Sunscreens in Australia
Regulation of Sunscreens in Australia Dr Cheryl McRae Assistant Secretary Complementary and OTC Medicines Branch The Sunscreen Summit, Brisbane, 19 March 2018 Regulation of Sunscreens in Australia In Australia,
More informationRegulation of Cosmetics in Korea. Chin SooYoung Consulting
Regulation of Cosmetics in Korea Chin SooYoung Consulting Classification in Korea Regulatory classification Quasi-drug (QD) Category Feminine Care Hair Care Oral Care Vitamins Anti-perspirant Anti septic
More informationALABAMA BOARD OF COSMETOLOGY ADMINISTRATIVE CODE CHAPTER 250-X-3 SALON REQUIREMENTS TABLE OF CONTENTS
ALABAMA BOARD OF COSMETOLOGY ADMINISTRATIVE CODE CHAPTER 250-X-3 SALON REQUIREMENTS TABLE OF CONTENTS 250-X-3-.01 General Requirements 250-X-3-.02 Products Sanitation And Care 250-X-3-.03 Shops 250-X-3-.04
More informationASKANESTHETICIAN'S BLOG. What Are Cosmeceuticals? January 17, categories. 1 de 6 02/09/ :00 ABOUT
ASKANESTHETICIAN'S ABOUT BLOG An esthetician explores skincare issues and concerns What Are Cosmeceuticals? January 17, 2011 Filed under: Beauty/Cosmetic Products,Skincare products askanesthetician @ 9:55
More informationAPPLICATION FOR BODY ART FACILITY PLAN REVIEW
APPLICATION FOR BODY ART FACILITY PLAN REVIEW The Kern County Public Health Services Department, Environmental Health Division shall issue a health permit for a body art facility after an investigation
More informationType of Application (Check One) New Protocol Revised Protocol Project Duration Start Date: End Date:
Page 1 of 11 INSTITUTIONAL BIOSAFETY COMMITTEE Winston-Salem State University Application for the Use of Biohazardous Materials, Recombinant DNA and Infectious Agents 1. APPLICANT INFORMATION Assigned
More informationChisum, et al. ORGANIZATION bill analysis 5/1/2007 (CSHB 2106 by Thompson) Revisions to barber and cosmetology regulations
HOUSE HB 2106 RESEARCH Chisum, et al. ORGANIZATION bill analysis 5/1/2007 (CSHB 2106 by Thompson) SUBJECT: COMMITTEE: VOTE: Revisions to barber and cosmetology regulations Licensing and Administrative
More informationRULES OF TENNESSEE STATE BOARD OF COSMETOLOGY CHAPTER SANITARY RULES TABLE OF CONTENTS
RULES OF TENNESSEE STATE BOARD OF COSMETOLOGY CHAPTER 0440-2 SANITARY RULES TABLE OF CONTENTS 0440-2-.01 Definitions 0440-2-.10 Animals 0440-2-.02 Applicability 0440-2-.11 High Frequency Electric Current
More informationProduct Information File & Cosmetic Product Safety Report
Product Information File & Cosmetic Product Safety Report October 2015 Compliance with Cosmetic Regulation EC No. 1223/2009 Product Information File and Cosmetic Product Safety Report Regulation EC No.
More informationBODY ART TEMPORARY EVENT SPONSOR APPLICATION PACKET
BODY ART TEMPORARY EVENT SPONSOR APPLICATION PACKET Attached are instructions for event sponsors and body artist participants. The information should be read carefully. The sponsor must work with the Kern
More informationChemical Inspection and Regulation Service (CIRS)
Guidance on Exporting Cosmetics to China April Guo, Regulatory Affairs Specialist for Cosmetics and Cosmetic Ingredient, april.guo@cirs-reach.com Chemical Inspection and Regulation Service (CIRS) 27 June
More informationFDA Continues Deluge of Warning Letters to Cosmetic and Dietary Supplement Manufacturers
COSMETICS COSMECEUTICALS DIETARY SUPPLEMENTS NUTRACEUTICALS DIETARY SUPPLEMENT CONTENTS FIRM NEWS Two Shook Partners Recognized for Excellence in FDA Law....1 SPOTLIGHT FDA Continues Deluge of Warning
More informationLuke Mulligan, State Bar # Asst. Federal Public Defender Attorney for Defendant IN THE UNITED STATES DISTRICT COURT
Case :-mj-00-mea Document 0 Filed 0/0/ Page of 0 JON M. SANDS Federal Public Defender District of Arizona N. San Francisco Street, Suite Flagstaff, AZ 00 Telephone: () - Fax: () - Luke Mulligan, State
More informationRULES OF TENNESSEE BOARD OF COSMETOLOGY AND BARBER EXAMINERS CHAPTER SANITARY REQUIREMENTS TABLE OF CONTENTS
RULES OF TENNESSEE BOARD OF COSMETOLOGY AND BARBER EXAMINERS CHAPTER 0200-03 SANITARY REQUIREMENTS TABLE OF CONTENTS 0200-03-.01 Applicability 0200-03-.02 Violations 0200-03-.03 Location 0200-03-.04 Communicable
More informationHealth & Safety Policy and Procedures Manual SECTION 26 HAZARD COMMUNICATION PROGRAM
SECTION 26 HAZARD COMMUNICATION PROGRAM 1. SCOPE: This is the Hazard Communication Program concerning the acquisition and dissemination of information for potentially hazardous chemical materials to be
More informationFEDERAL REGISTER NOTICE
FEDERAL REGISTER NOTICE DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Part 12 [CBP Dec. 06-22] RIN 1505-AB72 IMPORT RESTRICTIONS ON BYZANTINE
More informationCosmetic Products New EU Regulation Published
Cosmetic Products New EU Regulation Published From 11th July 2013 cosmetic products placed on the market within the European Economic Area1 (EEA) will have to comply with the new EU Cosmetic Products Regulation
More informationCONSOLIDATION UPDATE: DECEMBER 11, 2002
REPEALED BY THE BODY MODIFICATION BY-LAW NO. 40/2005 MARCH 23, 2005 (effective January 1, 2006) CONSOLIDATION UPDATE: DECEMBER 11, 2002 THE CITY OF WINNIPEG TATTOO STUDIO BY-LAW NO. 4653/87 A By-law of
More informationHazard Communication Program
1. Purpose The University of Denver Hazard Communication Program defines the requirements and responsibilities for informing and training employees about workplace hazardous chemicals in accordance with
More informationHOUSE OF REPRESENTATIVES STAFF ANALYSIS REFERENCE ACTION ANALYST STAFF DIRECTOR
HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: HB 117 Cosmetology SPONSOR(S): Carroll TIED BILLS: IDEN./SIM. BILLS: SB 920 REFERENCE ACTION ANALYST STAFF DIRECTOR 1) Jobs & Entrepreneurship Council 2)
More informationBody Art Technician License Application
Body Art Technician License Application INSTRUCTIONS AND APPLICATION MINNESOTA GOVERNMENT DATA PRACTICE ACT NOTICE. This notice is given pursuant to Minnesota Statutes, Sections 13.04, Subd. 2, and 13.41,
More informationASSEMBLY, No STATE OF NEW JERSEY. 216th LEGISLATURE INTRODUCED MARCH 10, 2014
ASSEMBLY, No. STATE OF NEW JERSEY th LEGISLATURE INTRODUCED MARCH 0, 0 Sponsored by: Assemblywoman ANNETTE QUIJANO District 0 (Union) SYNOPSIS Permits chair or booth rentals for the purpose of providing
More informationCHAPTER 18 LICENSURE AND REGULATION OF BODY PIERCING AND TATTOOING
CHAPTER 18 LICENSURE AND REGULATION OF BODY PIERCING AND TATTOOING 18.01 AUTHORITY AND PURPOSE 18.02 APPLICABILITY 18.03 DEFINITIONS 18.04 LICENSES 18.05 LIMITATIONS 18.06 RECORDS 18.07 HEALTH AND SANITARY
More informationFORMALDEHYDE EXPOSURE CONTROL PLAN
Page: 1 of 5 1.0 Purpose and Applicability 1.1 It is the policy of the University of Pennsylvania in coordination with the Office of Environmental Health and Radiation Safety to provide the University
More informationMeeting Agenda State College Borough Board of Health October 23, 2018 Room 242 / 4 p.m. Complete Board of Health Agenda - October 23, 2018.
I. II. III. IV. V. Call To Order Roll Call Approval Of Minutes Public Hour Business Meeting Meeting Agenda State College Borough Board of Health Room 242 / 4 p.m. A. B. Report On Department Activity (Copy
More informationAPPLICANT/BODY ART ESTABLISHMENT PERMIT STATEMENT OF CONSENT
9. Provide the Following With Application: A. (New & Renewal Applications) Present original and provide copy of Business Certificate issued by the Everett City Clerk under provisions ofmgl c. 110 subsection
More informationHAZARD COMMUNICATION PROGRAM
DRAFT SAMPLE WRITTEN HAZARD COMMUNICATION PROGRAM For Compliance With 1910.1200 Wyoming General Rules and Regulations Wyoming Department of Workforce Services OSHA Division Consultation Program ACKNOWLEDGEMENTS
More informationManchester Health Department Cosmetology Establishment Informational Forum
Manchester Health Department Cosmetology Establishment Informational Forum Monday March 11, 2019 10:00 AM to 11:00 AM Whiton Branch Library Auditorium 100 Main St Manchester, CT Meeting Agenda Introductions
More informationKing MediGrade FAQ. What type of finish? Matte gloss finish on both sides.
King MediGrade FAQ What is King MediGrade? King MediGrade is the antimicrobial polymer building sheet for healthcare applications. It is a super tough polymer building sheet with an advanced antimicrobial
More informationCombination Colors Optical Properties and Regulatory Update
Combination Colors Optical Properties and Regulatory Update PCPC Science Symposium October 3, 2012 Outline 1 History leading to current FDA dialogue on Combination Pigments 2 Optical and Physical Properties
More informationCase 3:07-cv MLC-JJH Document 1 Filed 08/21/2007 Page 1 of 12 THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY
Case 3:07-cv-04018-MLC-JJH Document 1 Filed 08/21/2007 Page 1 of 12 PINILISHALPERN, LLP GABRIEL H. HALPERN (GH 5395 237 South Street Morristown, New Jersey 07960 Tel: (973 401-1111 Fax: (973 401-1114 THE
More informationChinese Cosmetic Regulations Updates: How Will it Affect the Exports of Korean Cosmetics
Chinese Cosmetic Regulations Updates: How Will it Affect the Exports of Korean Cosmetics (CN) www. cirs-reach.com(en) 15 th Jun 2018, April Guo, General Manager, Personal Care Division Email: april.guo@cirs-reach.com
More informationSUBCHAPTER 14H - SANITATION SECTION SANITATION
SUBCHAPTER 14H - SANITATION SECTION.0100 - SANITATION 21 NCAC 14H.0101 COPY OF RULES TO COSMETOLOGY STUDENTS Cosmetic art schools shall give a copy of the sanitation rules governing the practice of the
More informationRULES OF TENNESSEE BOARD OF COSMETOLOGY AND BARBER EXAMINERS CHAPTER SANITARY RULES TABLE OF CONTENTS
RULES OF TENNESSEE BOARD OF COSMETOLOGY AND BARBER EXAMINERS CHAPTER 0440-02 SANITARY RULES TABLE OF CONTENTS 0440-02-.01 Definitions 0440-02-.10 Animals 0440-02-.02 Applicability 0440-02-.11 High Frequency
More informationEU position on cosmetics in TTIP Comparison between 2014 and 2015 versions
EU position on cosmetics in TTIP Comparison between 2014 and 2015 versions May 2014 March 2015 1. Introduction The final report of the US - EU High Level Working Group on Jobs and Growth of February 2013
More informationRE: NDA Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) MACMIS #17768 WARNING LETTER
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Francois Fournier, President and CEO 14501 North Freeway Fort Worth,
More informationChapter 67. BODY ART ESTABLISHMENTS (TATTOOING) Established (09-56)
Chapter 67 BODY ART ESTABLISHMENTS (TATTOOING) Established 9-28-09 (09-56) Sections: 67.01 DEFINITIONS. 67.02 BODY ART ESTABLISHMENT LICENSE REQUIRED. 67.03 QUALIFICATIONS FOR BODY ART ESTABLISHMENT LICENSE.
More informationSAC S RESPONSE TO THE OECD ALIGNMENT ASSESSMENT
SAC S RESPONSE TO THE OECD ALIGNMENT ASSESSMENT A Collaboration Between the Sustainable Apparel Coalition and the Organisation for Economic Cooperation and Development February 13, 2019 A Global Language
More informationStatutory Instrument 241 of S.I. 241 of 2018
Statutory Instrument 241 of 2018. S.I. 241 of 2018 2535 [CAP. 29:13 Marondera Rural District Council (Hairdresser s and Barber s ARRANGEMENT OF SECTIONS Section 1. Title. 2. Interpretation. 3. Hairdresser
More informationENVIRONMENTAL HEALTH SERVICE REQUEST FORM 2019
Environmental Health Division 1675 W. Garden of the Gods Rd., Suite 2044 Colorado Springs, CO 80907 (719) 578-3199 phone (719) 578-3188 fax www.elpasocountyhealth.org ENVIRONMENTAL HEALTH SERVICE REQUEST
More informationSignet Responsible Sourcing Protocol For Diamonds. Ensuring The Integrity Of The Natural Diamond Supply Chain. April 18, 2017
Signet Responsible Sourcing Protocol For Diamonds Ensuring The Integrity Of The Natural Diamond Supply Chain April 18, 2017 Agenda Introduction: Signet Responsible Sourcing Signet Responsible Sourcing
More informationFDA Regulation of Cosmetics and Personal Care Products
FDA Regulation of Cosmetics and Personal Care Products -name redacted- Analyst in Public Health and Epidemiology July 9, 2012 CRS Report for Congress Prepared for Members and Committees of Congress Congressional
More information