FDA WARNING_LETTER - Purechempros LLC - November 22, 2022

On September 1, 2023, the FDA issued a Warning Letter to PureChemPros LLC following an inspection from November 17-22, 2022. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Specific violations include: 1. **Failure of Quality Control Unit (21 CFR 211.22):** The firm lacked an adequate quality unit to oversee drug manufacturing, including PureCareRx Liquid Hand Sanitizer. 2. **Inadequate Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to test incoming components for identity, purity, strength, and quality, relying on unvalidated supplier COAs. Water used in manufacturing was also not tested for suitability. 3. **Lack of Stability Testing (21 CFR 211.137(a)):** The firm failed to implement a stability testing program to support product expiration dates.

Additionally, "35% FOOD GRADE HYDROGEN PEROXIDE" and "3% FOOD GRADE HYDROGEN PEROXIDE" were identified as unapproved new drugs, violating 21 U.S.C. 355(a) and 3