Foshan Yiying Hygiene Products Co., Ltd. — FDA Warning Letter Findings

Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)). Your response to our request for records and other information under section 704(a)(4) indicated that you did not perform stability testing. Therefore, you have not demonstrated that the active ingredient in your drug products is stable throughout its shelf life. Without appropriate stability data, you cannot ensure your drug products meet established specifications and all pre-determined quality criteria throughout their assigned shelf-life.

Your firm failed to establish adequate 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 (21 CFR 211.100(a)). Your response to our request for records and other information under section 704(a)(4) indicated that you did not ensure that your manufacturing processes are reproducible and controlled to yield a product of…

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Your firm manufactures OTC drug products, including (b)(4) . Your response to our request for records and other information under section 704(a)(4) indicated that you did not conduct adequate finished product testing on drug products shipped to the United States market. Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient, prior to release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your drug products conform to appropriate specifications before release.

Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). Your response to our request for records and other information under section 704(a)(4) indicated that you did not document all important steps in your manufacturing process. For example, in your response, you stated “…this site does not prepare batch production records for every batch of our…

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your response to our request for records and other information under section 704(a)(4) indicated that you did not adequately test the identity of incoming components used in the manufacture of your drug products. You also did not demonstrate that you are testing your active ingredient (b)(4) for (b)(4) . Without adequate testing you do not have scientific evidence that your raw materials conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality, including testing for the presence of (b)(4) in (b)(4) . The use of (b)(4) contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4) .