FDA Update. What s New? FDA Reorganization 9/13/2012. FDA Reorganization Role of Third Parties in Ensuring Supply Chain Integrity

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1 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 the Commissioner Office of Operations Office of Global Regulatory Operations and Policy Office of Foods Office of Medical Products and Tobacco 1

2 Office of Global Regulatory Operations and Policy Office of International Programs Office of Regulatory Affairs Office of Foods Center for Food Safety and Applied Nutrition Center for Veterinary Medicine Office of Medical Products and Tobacco Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Tobacco Products 2

3 FDA Abroad China Beijing, Shanghai, Guangzhou Europe London, England; Parma, Italy India New Delhi, Mumbai Latin America San Jose, Costa Rica; Santiago, Chile; Mexico City, Mexico FDA Abroad Middle East and North Africa Amman, Jordan Asia-Pacific Silver Spring, MD, USA Sub-Saharan Africa To be established Food Safety Modernization Act (FSMA) Imported Foods Third Party Certification Facilitate entry of imported foods into US Qualified third parties certify that foreign food manufacturers comply with US standards FDA to establish a system to recognize accreditation bodies Public Meeting held 3/29/11 3

4 Top 10 Drug Observations¹ Top 10 Drug Observations¹ 21 CFR (d) 21 CFR (b) 21 CFR (b) 21 CFR (a) 21 CFR CFR (a) 21 CFR (a) 21 CFR (a) 21 CFR (b) 21 CFR FDA Warning Letter Eye and Facial Moisturizers Unapproved new drugs Promoted to boost gene activity, stimulate youth proteins, stimulate cell regeneration, reduce wrinkles in sun-damaged skin, lift to recreate younger appearance 4

5 FDA Warning Letter Hair and Skin Sera and Creams Unapproved new drugs Promoted to strengthen hair growth and fight hair loss, reduce blemishes and breakouts, treat skin infections, prevent scarring and stretch marks, regenerate and stimulate cells Promoted as safe alternative to Botox, antimicrobial, antiseptic, anti-inflammatory FDA Warning Letter Foot Scrub Adulterated Injurious to health Excessive microbiological levels found in FDA sample Prepared, packed, or held under insanitary conditions Filth and dust on manufacturing equipment Raw materials not routinely evaluated from a microbiological safety standpoint Production areas not well-maintained or designed Finished products not routinely tested Class 2 Voluntary Recalls Tattoo Ink Contaminated with trace amounts of bacillus-type bacteria Hair Smoothing Kits Undesired treatment outcomes; customer confusion regarding how to use Night Moisturizer Contaminated with Staphylococcus aureus and fungus 5

6 Class 3 Voluntary Recalls Eye Make-Up Remover Prohibited color Other Topics of Interest Adverse Event Reporting and Complaints Intake, Investigation, Follow-up FDA Investigator Training Overview Part 11 Compliance Update Useful Links - Cosmetics FDA Cosmetics Webpage CPGM , Cosmetics Program: Import and Domestic RegulatoryInformation/ComplianceEnforcement/UCM pdf Good Manufacturing Practice (GMP) Guidelines/ Inspection Checklist atoryinformation/goodmanufacturingpracticegmpguidelin esinspectionchecklist/default.htm 6

7 Useful Links - Drugs FDA Office of Nonprescription Drugs Webpage DrugsareDevelopedandApproved/ucm htm Pharmaceutical cgmps for the 21st Century A Risk- Based Approach: Final Report, Fall ufacturing/questionsandanswersoncurrentgoodmanufacturi ngpracticescgmpfordrugs/ucm htm CPGM , Drug Manufacturing Inspections mplianceprogrammanual/ucm pdf Useful Links - Other FDA s Global Initiative FSMA References 1. Turbo EIR Reports (October 1, 2011 through September 13, 2012) 7