Findings citing 21 CFR 211.137

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). Based on the records and information you provided, you did not demonstrate that your quality unit (QU) adequately exercised its authority and responsibilities for the manufacture of your OTC drug products. For example, your QU failed to ensure the following: Establishing appropriate written procedures for production and process controls to qualify process performance and for qualification of your (b)(4) system, which produces (b)(4) used as a component in your drug products (21 CFR 211.100(a)). Maintaining complete manufacturing information relating to the production and control in batch records (21 CFR 211.188). Providing appropriate stability data to support the labeled drug product expiration date (21 CFR 211.137(a)). Establishing adequate QU authority and procedures (21 CFR 211.22(a) & 211.22(d)). Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA guidance documents Quality Systems Approach to Pharmaceuticals CGMP Regulations at https://www.fda.gov/media/71023/download. Drug Registration and Listing We note that two separate establishments are referenced in this warning letter. Under section 510(i) of the FD&C Act and 21 CFR 207.17(a) any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the United States must be registered with FDA. Under section 301(p) of the FD&C Act, 21 U.S.C. 331(p), it is a prohibited act to fail to register an establishment as required by section 510 of the FD&C Act. Additionally, a drug may be considered misbranded within the meaning of section 502(o) of the FD&C Act, 21 U.S.C. 352(o) if it was manufactured in an establishment not duly registered under section 510 of the FD&C Act. It is your responsibility to ensure that all drugs manufactured at your establishment(s) comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. CGMP Consultant Based upon the nature of the violations we identified in your response, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

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…