Another Sunscreen Manufacturer (Jaychem Industries, Ltd.) Receives Warning Letter (090415)

The FDA identified significant violations of current good manufacturing practice (CGMP) regulations during an audit (July 7-10, 2014) of Jaychem Industries, Ltd., Auckland New Zealand and their finished pharmaceuticals, Unfortunately, several other firms to include W.S. Badger Co (Click here) (September 23, 2013), a sunscreen manufacturer, had a huge recall for microbial contamination.  Both firms failed to ensure the quality of components and assure chemical properties remained acceptable throughout their shelf life.

These violations cause the 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, the manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP.

The FDA subsequently issued a Warning Letter (Click here) after the firm’s response was found to lack sufficient corrective actions. These included:

1. “You failed to ensure the quality of components, including your (b)(4)active ingredients from various suppliers (21 CFR 211.84(d)(1) and (2)).
2. You failed to establish adequate written control procedures to monitor (b)(4)during manufacturing (21 CFR 211.110(a)).  You stated that you released all (b)(4) lotions regardless of (b)(4) 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 211.165(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 211.166(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.” 

COMMENT

Sunscreen manufacturers have within recent years suffered either recalls or Warning Letters from the FDA because of inadequate controls of in-coming raw materials, failure to test finished batches for identity and strength of active ingredients and demonstration of satisfactory chemical and physical properties throughout the shelf life of the products.  Many of these products have been on the market for significant periods of time and, while the products may have met specifications at one time, many of the products may have been altered by their vendors modifying their materials as well as the manufacturing process itself.

An issue that was not noted in the Jaychem Warning Letter dealt with the possibility of microbial contamination of the products manufactured.  Nothing was mentioned regarding USP<51> Antimicrobial Effectiveness Test — when was it last performed on these products, were the raw materials to include the preservatives still considered the same in terms of microbial content and efficacy as when initially formulated, when were the raw materials last investigated for microbial content, etc.

Because such a variety of microorganisms were isolated and identified in the W.S. Badger Co. recall, there is a definite suggestion that the in-coming raw materials and/or the plant may be contaminated here with Jaychem Industries, Ltd. as well.  It is also possible that the FDA investigator investigating Jaychem did not possess a microbiological background and was oblivious to microbiological issues.

In addition, with the new Process Validation Guidance from the FDA, the use of continuous monitoring within Stage 3 and the possibility for contamination reminds us that one can’t venture into “Continued Process Verification” without recognizing that this may become one of the consequences.