Macau-Union Pharmaceutical Limited — FDA Warning Letter Findings

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, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)). Your firm lacks process validation studies to demonstrate reproducibility and control of your manufacturing…

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 firm failed to test incoming active pharmaceutical ingredients (APIs) (e.g. (b)(4) ) and other components used to manufacture your OTC drug…

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, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and 211.165(b)). Your firm did not adequately test your over-the-counter…

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)). You failed to establish an adequate stability testing program to support the labeled expiration date on your distributed drug products in the U.S. market. There is no assurance that your OTC drug products will remain acceptable throughout the labeled (b)(4) expiry period without an ongoing stability program. In your response, you…