Findings
1Equipment and facility
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You manufacture over-the-counter (OTC) drug products, (b)(4) Hand Sanitizer Foam, both alcohol and alcohol-free formulas, using the same equipment that you use to manufacture non-drug products, including industrial cleaning detergents and disinfectants such as Bowl Cleaner, a strongly acidic (pH <2) toilet cleaner, and (b)(4) . In your response…
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. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., benzalkonium chloride, ethanol, glycerin)…
3Quality 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) failed to exercise its responsibility to adequately review production records prior to approval (e.g., failed to investigate out-of-specification test results, reprocessing, and errant label reconciliation) and failed to…
About this record
Extracted automatically from the document US FDA published on 2025-12-09. 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.
