Clean Cosmetics LLC – FDA Warning Letter, Aug 19, 2022

The FDA issued a Warning Letter to Clean Cosmetics LLC following an inspection from August 11-19, 2022, and a review of submitted records. The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals, rendering their drug product adulterated.

Key violations include: 1. **Failure to test components:** The firm did not conduct identity testing for incoming components, including ethanol for hand sanitizer, relying solely on supplier COAs without validation. Notably, ethanol containing unacceptable levels of methanol was used to manufacture and release hand sanitizer lots. 2. **Inadequate finished product testing:** The firm failed to perform microbial and impurity testing on finished hand sanitizer products, lacking scientific evidence of conformance to specifications prior to release. 3. **Deficient Quality Control Unit (QCU):** The QCU failed to ensure CGMP compliance and product specifications. The firm lacked essential procedures for investigations, CAPAs, change controls, recalls, supplier qualification, equipment cleaning, and water system monitoring. The QCU also released components and finished lots without proper testing.

The FDA previously requested information regarding methanol-contaminated hand sanitizer and publicly notified consumers about the TrustRX Medical Grade Hand Sanitizer. The firm committed to destroying adulterated product, which was observed.

The FDA recommends engaging a qualified CGMP consultant and clarifies that the firm's executive management remains responsible for compliance. The firm has ceased drug production, and the FDA requires clarification on future manufacturing plans. A