Findings
1Computer system validation
Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm lacked sufficient controls over your liquid chromatography (LC) and gas chromatography (GC) instrument used to test drug products prior to release. Specifically, your firm did not appropriately control administrative privileges for file…
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) did not provide adequate oversight for the manufacture and release of your over-the-counter (OTC) drug products. For example, you filled batch (b)(4) of your (b)(4) Spray from vessels (b)(4) . Your QU rejected the drug…
3Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You failed to adequately investigate multiple microbial excursions reported for objectionable microorganisms found during testing of your OTC drug products. For example, objectionable microorganism Staphylococcus aureus (S. aureus) was identified during…
About this record
Extracted automatically from the document US FDA published on 2025-09-02. 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.
