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)). Based on the records and information you provided, you did not demonstrate that you adequately tested your OTC IPA prep pad drug product for the identity and strength of the active ingredient, IPA, prior to…
2Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. (21 CFR 211.84(d)(1)). Based on the records and information you provided, you did not demonstrate that you adequately tested the identity of your incoming components including glycerin, propylene glycol, ethanol, and IPA that are used in the manufacture of your OTC drug products. For example, your May 6, 2024 response…
3Aseptic processing and sterility assurance
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 manufactured over-the-counter (OTC) isopropyl alcohol (IPA) prep pad drug products, labeled as sterile, that are intended as an antiseptic for preparation of the skin prior to an injection. Based on the records and information you…
About this record
Extracted automatically from the document US FDA published on 2024-11-12. 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.
