Findings
1Quality 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 have adequate procedures and personnel with the CGMP responsibilities for oversight for the manufacture of your over-the-counter (OTC) drug products. You could not identify any personnel with the responsibility and authority…
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)). Inadequate Process Controls Your production instructions and production records were inadequate to ensure consistent manufacture of OTC drug products. Your hand sanitizer manufacturing “recipe” lacked critical…
3Laboratory 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)). Your firm failed to perform adequate drug product testing prior to release to the market. You could not provide a list of tests, specifications, or test procedures used as part of batch release. Likewise, you…
About this record
Extracted automatically from the document US FDA published on 2022-11-29. 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.
