Jaychem Industries Ltd 9/4/15

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1 Jaychem Industries Ltd 9/4/15 Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring, MD VIA UPS RETURN RECEIPT REQUESTED Warning Letter WL: September 04, 2015 Richard Jancys General Manager (Director) Jaychem Industries, Ltd. PO Box Pakuranga Auckland, 2140 New Zealand Dear Mr. Jancys: During our July 7-10, 2014 inspection of your pharmaceutical manufacturing facility, Jaychem Industries, Ltd. at 3 Kordel Place, East Tamaki, Auckland, New Zealand, 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. 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 FD&C Act), 21 U.S.C. 351(a)(2)(B), in that 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, your firm also manufactures misbranded drugs in violation of the FD&C Act under Sections 502(a), 21 U.S.C. 352(a); 502(c), 21 U.S.C. 352(c); 502(f)(1), 21 U.S.C. 352(f)(1); and 502(f)(2), 21 U.S.C. 352(f)(2). After a detailed review of your firm s response dated July 17, 2014, we note that it lacks sufficient corrective actions.

2 CGMP Violations Our investigators observed specific violations during the inspections, including, but not limited to, the following. 1. You failed to ensure the quality of components, including your (b)(4) active ingredients from various suppliers (21 CFR (d)(1) and (2)). 2. You failed to establish adequate written control procedures to monitor (b)(4) during manufacturing (21 CFR (a)). You stated that you released all (b)(4) lotions regardless of (b)(4) results. The effectiveness of (b)(4) Lotion is (b)(4). 3. You failed to test finished batches for the identity and strength of active ingredients (21 CFR (a)). 4. You have no data to demonstrate that the chemical and physical properties of (b)(4) Lotion remain acceptable throughout its (b)(4) shelf life (21 CFR (a)). Your quality unit released at least (b)(4) batches of (b)(4) Lotion for distribution, despite the above violations, as well as others cited on the July 10, 2014, Form FDA 483. According to your firm s response of July 17, 2014, you will hire a third-party contract laboratory to perform testing. You will also develop and implement an action plan to ensure that stability testing is performed and that your product expiry date is justified. In addition, you will ensure that components and drug products are adequately tested for conformity to specifications. However, you failed to provide adequate details of these plans, including how you will ensure that your Quality Unit carries out essential functions such as rejecting and investigating any components, in-process materials, and drug products that do not conform to specifications. You also failed to include a retrospective review of all your drug products distributed to the U.S. that remain within expiry. You should evaluate the causes and impact of (b)(4) variation. You should also determine your products compliance with specifications, adequacy of specifications and procedures, adequacy of manufacturing processes, acceptability of documentation practices, and sufficiency of your investigations of discrepancies. Misbranding Violations The labels for GolfersSkin SPF 30 Plus WR80 Sunscreen Lotion (4.2 fl oz) and GolfersSkin SPF 30 Plus Sunscreen Lip Balm state that they are intended to prevent sunburn. Therefore, these products are drugs as defined in Section 201(g) of the FD&C Act, 21 U.S.C. 321(g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man. Over-the-Counter (OTC) sunscreen drugs, such as GolfersSkin SPF 30 Plus WR80 Sunscreen Lotion (4.2 fl oz) and GolfersSkin SPF 30 Plus Sunscreen Lip Balm, are subject to among other regulations the OTC sunscreen drug products; required labeling based on effectiveness testing (21 CFR ). As explained below, these products are misbranded.

3 GolfersSkin SPF 30 Plus WR80 Sunscreen Lotion (4.2 fl oz) and GolfersSkin SPF 30 Plus Sunscreen Lip Balm are misbranded under Section 502(c) of the FD&C Act [21 U.S.C. 352(c)] because Broad Spectrum and SPF 30 appear separately and in different font sizes on the products principal display panels. Per 21 CFR (a)(1)(i)(B), the Broad Spectrum statement must appear as Broad Spectrum SPF [insert numerical SPF value resulting from testing] and the prominence of this statement must appear as continuous text with the same font style, size, and color. Additionally, GolfersSkin SPF 30 Plus Sunscreen Lip Balm is further misbranded under Section 502(c) of the FD&C Act, because it is not labeled consistent with the labeling requirements for Water Resistance level under 21 CFR (a)(2), in that it fails to state the required Water Resistance level information prominently on the label. For these reasons, GolfersSkin SPF 30 Plus WR80 Sunscreen Lotion (4.2 fl oz) and GolfersSkin SPF 30 Plus Sunscreen Lip Balm are misbranded within the meaning of Section 502(c) of the FD&C Act because the required information does not appear prominently on the labeling. GolfersSkin SPF 30 Plus WR80 Sunscreen Lotion (4.2 fl oz) and GolfersSkin SPF 30 Plus Sunscreen Lip Balm are also misbranded under Section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), because the product labels do not include all of the applicable directions required under 21 CFR (e). GolfersSkin SPF 30 Plus WR80 Sunscreen Lotion (4.2 fl oz) fails to include the direction for use, [bullet] reapply [bullet] after 40 [or 80] minutes of swimming or sweating, [bullet] immediately after towel drying, [bullet] at least every 2 hours as required by 21 CFR (e)(3). GolfersSkin SPF 30 Plus Sunscreen Lip Balm fails to include the following directions for use, [bullet] Sun Protection Measures. [in bold font] Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: [Bullet] limit time in the sun, especially from 10 a.m. 2 p.m. [bullet] wear long-sleeved shirts, pants, hats, and sunglasses, and [bullet] reapply after 40 [or 80] minutes of swimming or sweating, [bullet] immediately after towel drying, [bullet] at least every 2 hours as required by 21 CFR (e)(2) and (e)(3) respectively. GolfersSkin SPF 30 Plus Sunscreen Lip Balm is misbranded under Section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the Uses section of the Drug Facts panel states Higher SPF gives more sunburn protection and Provides high protection against sunburn. As explained in the Final Rule Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use, 76 FR (June 17, 2011), these statements are misleading since characterizations such as low, medium, high, or highest are no longer used or permitted by the Agency and therefore would confuse the consumer. The time spent in the sun is a truthful and non-misleading statement that may appear outside of Drug Facts (76 FR (June 17, 2011)). GolfersSkin SPF 30 Plus Sunscreen Lip Balm is misbranded under Section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the product label does not include the warning, Do not use [bullet] on damaged or broken skin as required by 21 CFR (d)(1). Summary

4 Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating the violations identified above, determining their causes, preventing their recurrence, and preventing other violations. Based upon the nature of the CGMP violations we identified at your firm, we recommend that you engage a third-party consultant with appropriate CGMP expertise to comprehensively assess your firm s facility, procedures, processes, laboratory controls, and quality management systems to ensure that the drug products you manufacture consistently are of appropriate identity, strength, quality, and purity. FDA is aware that many manufacturers of pharmaceutical products use contract testing laboratories. Such facilities are to be regarded as extensions of your facility. Regardless of who performs your operations, or your agreements in place, you are required to ensure that your products are produced and tested in accordance with Section 501(a)(2)(B) of the FD&C Act which covers identity, strength, quality, purity, safety, and suitability for marketing. See our draft Guidance for Industry Contract Manufacturing Arrangements for Drugs: Quality Agreements. Download at: m pdf Until you complete all corrections, and FDA confirms corrections of the violations and your firm s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. Your failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Jaychem Industries, Ltd. at 3 Kordel Place, East Tamaki, Auckland, New Zealand, into the United States under Section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Within 15 working days of receipt of this letter, please notify this office, in writing, of the specific steps that you have taken to correct and prevent the recurrence of violations. Provide supporting documentation. If you cannot complete corrective actions within 15 working days, state the reasons for the delay and the date by which you will have completed the corrections. If you no longer manufacture or distribute the drug products at issue, provide the date(s) and reason(s) you ceased production. Send your reply to: David S. Jones, Compliance Officer Food & Drug Administration White Oak 51 Room New Hampshire Ave Silver Spring, MD Please identify your response with FEI # Sincerely, /S/ Thomas J. Cosgrove, J.D. Director Office of Manufacturing Quality

5 Office of Compliance Center for Drug Evaluation and Research

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