FDA WARNING_LETTER - Frenda Corporation - August 01, 2022

The FDA inspected Frenda Corporation's drug manufacturing facility from July 26 to August 1, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations. The drug products are deemed adulterated under section 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act due to insanitary conditions and non-conformance to CGMP regulations (21 CFR parts 210 and 211).

Key violations include: 1. **Insanitary Conditions:** Presence of insects and filthy conditions, including insects in container closures, a consumer complaint of an insect in hand sanitizer, and inadequate separation of drug manufacturing from industrial chemical production. 2. **Lack of Defined Areas (21 CFR 211.42(c)):** Manufacturing OTC drugs and industrial chemicals (including caustic/acidic detergents) using the same equipment (mixing tanks, Filling Line (b)(4)) without proper separation, risking cross-contamination. 3. **Equipment Maintenance (21 CFR 211.67(a)):** Equipment in disrepair (rust-like residues, dirty/damaged seals on nozzles), lack of written cleaning procedures, and equipment use logs for shared filling lines. 4. **Inadequate Production and Process Controls (21 CFR 211.100(a) and (