FDA WARNING_LETTER - Prime Lab LLC - August 04, 2023

The FDA inspected Prime Lab LLC's drug manufacturing facility in Ponce, Puerto Rico, from July 31 to August 4, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to test components:** The firm did not adequately test incoming raw materials, including identity testing for each component lot of OTC antibacterial hand soap and hand sanitizer. They relied on supplier Certificates of Analysis (COA) without validating their reliability, posing risks like contamination with diethylene glycol (DEG), ethylene glycol (EG), or methanol. The firm's response was inadequate, lacking details on identity testing, COA validation, and assessment of distributed products. 2. **Inadequate cleaning and maintenance procedures:** The firm lacked sufficient written procedures for equipment cleaning and maintenance. Their response was inadequate, failing to retrospectively assess finished drug products for cross-contamination risk and lacking sufficient detail on revised procedures. 3. **Inadequate quality unit (QU):** The QU failed to provide adequate oversight, including ensuring robust procedures, continuous oversight, complete batch reviews, and approval of investigations. The firm's response was inadequate, lacking details on QU improvements, impact assessment of insufficient oversight, and improvements to the water system, finished product release testing, and microbiology testing.

The firm has committed to ceasing drug production. The FDA requires clarification on future manufacturing plans. Due to the nature