Findings citing 21 CFR 211.137

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…

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 firm assigned a (b)(4) expiry period to your OTC topical pain relief product without scientific rationale to support the labeled expiry. At the time of inspection, you lacked stability data to support the (b)(4) expiry period. There was no assurance that your drug product will remain acceptable throughout its labeled expiry…

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) lacked adequate control over your OTC drug product manufacturing operations and failed to ensure that you had adequate procedures. For example, your quality unit (QU) failed to ensure the following: Establishment of…

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’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). You lacked adequate quality oversight for the manufacture of your drug products. For example, you failed to ensure: Establishment of suitable quality oversight procedures (e.g., raw material handling, review of production records…

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: Establishment of an adequate stability program (21 CFR 211.137). Establishment of adequate…