Findings citing 21 CFR 211.165

Your firm failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(b)). You failed to ensure adequate microbiological testing for each batch of your drug product prior to release. Your non-compendial test method used to determine microbiological attributes (e.g., total count, objectionable microorganisms) for your finished OTC drug product was inadequate. Specifically, you lacked appropriate incubation times, lacked appropriate method suitability, and lacked positive and negative controls. In addition, you did not validate this non-compendial method. Your response is inadequate. You state that a contract laboratory will perform validation of United States Pharmacopeia (USP) <61> and <62> test methods for future release testing. While you submitted your Laboratory Controls and Test Method Management procedure and CAPA-2026-005, which references validation planning for microbiological methods, your response does not demonstrate adequate corrective actions to ensure that distributed product was appropriately tested prior to release, nor does it include a retrospective assessment of product quality. Testing is essential to ensure that the drug product you manufacture conform to all predetermined quality attributes appropriate for their intended use. Because you lacked adequate testing of each batch of your drug products, you do not know whether they conform to all appropriate finished-product specifications and are suitable for release to consumers. In response to this letter, provide: A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision. An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter. A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard-quality drug products, take rapid corrective actions, such as notifying customers and product recalls.

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) failed to perform adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following: Establishment of adequate written responsibilities and procedures applicable to the…

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 establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). Your response to our request for records under section 704(a)(4) indicated that you failed to adequately validate the test method used to analyze raw materials and finished drug products. Method validation or verification has not been completed for the active ingredient assay testing for (b)(4) . Your analytical method does not…

Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). You failed to adequately validate your alternative rapid microbiological test methods. You use the Neogen Soleris Next Generation System for rapid microbiological testing of your finished drug products (e.g., total aerobic counts, total counts, specified microorganisms) and failed to demonstrate that it was equivalent to or better…

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. Your firm also failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). Your firm failed to conduct…