FDA WARNING_LETTER - Avaria Health & Beauty Corp. - April 30, 2024

The FDA issued a Warning Letter to Avaria Health & Beauty Corp. following an inspection from April 22-30, 2024, at their Cambridge, Ontario, facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under the FD&C Act.

Key violations include: 1. **Failure to identity test components (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming components, specifically each shipment of each lot of (b)(4), for identity, including a (b)(4) limit test, despite its high risk for (b)(4) and (b)(4) contamination. The firm's response was deemed inadequate for lacking sufficient detail on future testing and not addressing distributed products within expiry. 2. **Inadequate production and process control procedures (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes and qualify equipment for OTC drug products, with the Quality Assurance Manager stating it was not their practice. The response lacked a detailed plan or supporting documentation for validation. 3. **Quality control unit failure (21 CFR 211.22):** The quality unit did not provide adequate oversight, failing to ensure robust procedures, adherence to practices, complete batch reviews, and approval of investigations.

These are repeat violations from a previous Warning