FDA 483 - Blue Ridge Pharmacy and Compounding Center - October 23, 2013

During an inspection from October 15-23, 2013, the FDA identified significant deficiencies at Blue Ridge Pharmacy and Compounding Center, a producer of sterile drug products. The observations, documented in an FDA Form 483, primarily highlighted critical lapses in aseptic processing, quality control, and adherence to Good Manufacturing Practices. Key issues included a severely compromised aseptic processing environment: the ISO 5 cleanroom lacked proper HEPA filtration and positive pressure, was situated in an unclassified, carpeted room with porous surfaces, and lacked pressure differential monitoring. Furthermore, the firm failed to maintain adequate cleaning and disinfection records, did not use sporicidal agents, and introduced un-disinfected items into the cleanroom. The inspection also revealed a lack of crucial validation and testing. There were no media fills to validate sterile processes, no dynamic smoke studies to confirm unidirectional airflow, and no routine sterility or endotoxin testing for sterile injectable products like QuadMix and Trimix. Critically, out-of-specification potency results were found, but no investigations were conducted, and affected products were still distributed. Documentation was poor, with incorrect component lot numbers recorded and compounding steps not properly delineated. The firm lacked a stability testing program to support product expiration dates, and personnel attire during aseptic operations was inadequate, consisting only of non-sterile gloves and a face mask. These findings require comprehensive corrective actions to ensure product safety and quality.