FDA WARNING_LETTER - Yusef Manufacturing Laboratories, LLC - September 24, 2021

The FDA issued a Warning Letter to Yusef Manufacturing Laboratories, LLC, following an inspection from September 20-24, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test components:** The firm did not adequately test incoming components, like ethanol for hand sanitizers, for identity, purity, strength, or quality, relying on unqualified supplier COAs. For example, ethanol was accepted based only on color, odor, and appearance, despite the supplier's COA stating it was not for drug manufacturing. 2. **Inadequate OOS investigations:** Investigations into out-of-specification (OOS) laboratory results were incomplete, lacked scientific conclusions, and had insufficient corrective and preventive actions (CAPA). An SPF30 Lip Balm Sunscreen batch with failing API assay results was released after retesting without a thorough investigation into the manufacturing process. 3. **Insufficient laboratory controls:** The firm lacked suitable analytical instrumentation and test methods for hand sanitizer assay, active ingredient identity, and impurity limits (e.g., methanol). Microbiological test methods for water and finished products were not demonstrated as suitable, and growth promotion testing for media was not conducted. 4. **Lack of process validation:** Manufacturing processes were not adequately validated to ensure reproducibility and consistent drug quality. 5. **Inadequate stability program:**