FDA 483 - Prime Lab LLC - August 04, 2023

Prime Lab LLC, a drug manufacturer in Ponce, PR, was inspected and cited for severe deficiencies across its quality system, laboratory controls, materials management, facilities, equipment, and production processes. The firm lacks fundamental procedures, documentation, and oversight for critical manufacturing operations, including quality control, product testing, stability, raw material identity, contamination prevention, equipment maintenance, and process controls. These issues indicate a pervasive failure to adhere to good manufacturing practices.