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 quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: Adequate written procedures for production and process controls (21 CFR 211.100(a)). …
2Laboratory 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 manufacture over-the-counter (OTC) drug products including alcohol-based hand sanitizer, anti-bacterial hand soap, isopropyl alcohol, and hydrogen peroxide. Your firm failed to adequately test your OTC…
3Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm manufactures OTC drug products without adequate assurance of the quality of raw materials. For example, you did not test incoming raw materials, including identity testing of each component lot used in the manufacture of your OTC drug products. Without adequate testing, you do not have scientific evidence that the components conform to…
About this record
Extracted automatically from the document US FDA published on 2024-04-16. 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.
