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 (21 CFR 211.165(a)). You failed to perform analytical and microbiological release testing for each batch of your over-the-counter (OTC) topical drug products prior to distribution, including Xpasmo Manteca de Ubre (Cow’s Udder…
2Quality 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 failed to establish an adequate Quality Unit (QU) to ensure that: Adequate procedures were established and written for roles and responsibilities of the QU to have the responsibility and authority to review and approve quality related…
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)). You failed to test all your incoming raw materials including active pharmaceutical ingredients (API) and other components. You relied on your supplier’s certificate of analysis (COA) in lieu of testing…
About this record
Extracted automatically from the document US FDA published on 2023-02-28. 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.
