AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp – FDA Warning Letter, Aug 7, 2024

The FDA issued a Warning Letter to AmWiner & Raphe Holdings LLC following an inspection from June 20 to August 7, 2024, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to conduct adequate final product testing (21 CFR 211.165(a))**: The firm released drug products, including those with minoxidil, without sufficient testing for identity and strength of active ingredients. Their response to use a contract lab was deemed inadequate without details on ensuring quality standards or a risk assessment for previously released products. 2. **Lack of established production and process control procedures (21 CFR 211.100(a))**: The firm failed to complete equipment and process performance qualification (PPQ) and lacked proper documentation, qualification, maintenance, and monitoring of their purified water system. Their response was insufficient, lacking validation protocols, reports, or timelines. 3. **Inadequate component identity testing (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm did not adequately test incoming components, including propylene glycol and minoxidil, for identity, and relied on supplier COAs without validating their reliability. Specifically, propylene glycol was not tested for diethylene glycol (DEG) and ethylene glycol (EG) contamination. Their