FDA 483 - Pharmagen Laboratories, Inc - August 23, 2013

An FDA inspection conducted at Pharmagen Laboratories, Inc., a sterile injectable drug manufacturer in Stamford, CT, from August 5-23, 2013, revealed significant deficiencies across its operations. The inspection highlighted a lack of compliance with Current Good Manufacturing Practices (cGMP) as outlined in 21 CFR 210/211. Key violations included a severely deficient Quality System, lacking a separate Quality Control Unit, written procedures, and proper investigation of product discrepancies, microbial test failures, rejected units, and customer complaints. Several drug lots were distributed without proper release signatures. The Production System showed inadequate validation of sterilization processes, including issues with pooling lots, filtration, and depyrogenation. Aseptic personnel practices and gowning were found deficient. Facilities and Equipment issues encompassed a lack of smoke studies, unqualified cleanroom areas, an inadequate environmental monitoring program, and poor cleaning. Calibration of critical equipment was also found lacking. The Laboratory Control System suffered from unvalidated test methods, insufficient potency testing for numerous sterile injectable products, and the absence of a comprehensive written stability program to establish expiration dates. The firm is expected to respond to these observations with a detailed plan for corrective and preventive actions to ensure full compliance with cGMP regulations.