Compounding Pharmacy of America – FDA 483, May 21, 2015

An FDA inspection conducted from May 12-21, 2015, at The Compounding Pharmacy of America, a producer of sterile drug products, revealed significant deviations from regulatory requirements. The observations highlighted critical failures across various operational areas essential for ensuring sterile product quality and patient safety. Key issues included a complete lack of sterility and endotoxin testing for finished products, along with unvalidated sterilization and depyrogenation processes for containers and components. The firm demonstrated severe deficiencies in preventing microbiological contamination, such as inadequate environmental controls, improper gowning and aseptic techniques, and the compounding of sterile drugs in unclassified, non-HEPA filtered rooms. Environmental monitoring was insufficient, and critical areas lacked appropriate air pressure differentials and continuous monitoring. Furthermore, the inspection noted a failure to establish a robust quality control unit, evidenced by uninvestigated microbial contamination of distributed products and inadequate complaint handling. Personnel attire and practices were unsuitable for sterile manufacturing, and critical equipment lacked calibration. The company also lacked stability testing to support assigned expiration dates and relied solely on supplier certificates of analysis without verifying raw material identity. Incomplete batch records and poor segregation of materials further compounded the compliance issues. The FDA 483 document outlines these observations, requiring the company to implement comprehensive corrective actions to address these systemic failures and ensure adherence to Good Manufacturing Practices for sterile drug production.