FDA WARNING_LETTER - Avaria Health & Beauty Corp. - August 08, 2023

The FDA issued a Warning Letter to Avaria Health & Beauty Corp. on August 3, 2023, following a review of records submitted on January 25, 2023, under section 704(a)(4) of the FD&C Act. The facility, registered as an OTC drug manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to conduct identity testing for components (21 CFR 211.84(d)(1)):** The firm did not adequately test high-risk components like glycerin for diethylene glycol (DEG) or ethylene glycol (EG) contamination using USP identity tests, failing to ensure component acceptability. 2. **Inadequate quality control unit (21 CFR 211.22(a)):** The Quality Unit (QU) did not effectively oversee drug manufacturing, specifically failing to approve or reject components in the Materials System, raising concerns about oversight in other CGMP operations.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations, perform a comprehensive six-system audit, and assess corrective actions. The firm was placed on Import Alert 66-40 on April 14, 2023. A written response detailing