FDA WARNING_LETTER - Art of Beauty Company, Inc. - December 01, 2023

The FDA inspected Art of Beauty Company Inc. (FEI 3012821715) in Bedford, Ohio, from November 27 to December 1, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Quality Control Unit (QCU):** The QCU lacked sufficient oversight, procedures for investigations, CAPAs, change controls, recalls, complaints, and equipment maintenance. The firm's response was deemed inadequate for not addressing all missing procedures, timelines, or a retrospective risk assessment. 2. **Failure to Test Components:** The firm did not adequately test incoming components, including high-risk ones like glycerin, for identity or contaminants like diethylene glycol (DEG) or ethylene glycol (EG) before manufacturing OTC hand sanitizer. The response was inadequate for not committing to a retrospective impact assessment or a timeline for testing distributed products. 3. **Insufficient Laboratory Testing:** The firm failed to test hand sanitizer for microbial contamination and did not adequately test its water system. Finished hand sanitizer products were not tested for identity and assay of isopropyl alcohol prior to release. 4. **Lack of Process Validation:** The firm failed to validate manufacturing processes for OTC drug products. The response was inadequate for not committing to testing distributed products without validation, ensuring prospective Process Performance Qualification (PPQ) studies, or providing a risk assessment