Findings
1Laboratory and QC controls
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 conduct for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). Your firm failed to adequately test the…
2Process validation
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 firm failed to conduct process validations for the OTC drug products you manufacture intended for the U.S. market. Process validation evaluates the soundness of design and state of control of a process…
3Material and supplier control
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)). Inadequate API Testing Your firm failed to ensure that incoming lots of active pharmaceutical ingredients (API) were suitable for use in manufacturing. For example, your firm used menthol and (b)(4) to…
4Quality unit oversight
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 firm lacked adequate procedures for an effective Quality Management System, including procedures describing the roles and responsibilities and controls for your quality unit over your OTC drug product manufacturing operations. You could not…
About this record
Extracted automatically from the document US FDA published on 2024-10-22. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
