Orean Personal Care Ltd. – FDA Warning Letter, Mar 15, 2024

On August 29, 2024, the FDA issued a Warning Letter to Orean Personal Care Ltd. following an inspection from March 11-15, 2024, at their Cleckheaton, UK facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test components for identity and conformity (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm did not perform adequate identity testing for each component lot, including the API for OTC drug products, and relied on supplier COAs without validating their reliability. This is a repeat finding from a 2017 inspection. The firm's response was inadequate, lacking specificity on testing plans and a retrospective risk assessment for products on the market. 2. **Failure to establish adequate written procedures for production, process control, cleaning, and maintenance (21 CFR 211.100(a) and 211.67(b))**: * **Lack of Process Validation**: The firm failed to adequately validate manufacturing processes, a repeat finding from 2017. Their response lacked supportive documentation, timelines, and a retrospective