Findings
1Stability and storage
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 three-year expiry period to ethyl alcohol antiseptic wipes without scientific rationale to support the labeled expiry. At the time of inspection, you lacked stability data to substantiate the three-year expiry period and there was no assurance that your drug products will remain acceptable throughout their…
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 quality unit (QU) lacked adequate control over your OTC drug manufacturing operations and failed to ensure that you had adequate procedures. For example, your QU failed to ensure: Adequate validation of manufacturing processes for ethyl…
3Material and supplier control
Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)). You failed to perform adequate identity testing on each lot of ethyl alcohol and benzylkonium chloride used to manufacture your OTC drug products. Because you did not perform adequate identity testing on each shipment of each lot, you failed to assure the acceptability of these components for use in the…
4Laboratory 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 released over-the-counter (OTC) (b)(4) drug products without adequate quality control testing, including but not limited to the identity and strength of each active ingredient. For example, identity and…
About this record
Extracted automatically from the document US FDA published on 2024-07-23. 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.
