Purechempros LLC – FDA Warning Letter, Nov 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
ID · a6dd5078-7241-44f4-b852-a491d5d6f52c
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.