FDA 483 - Pharmedium Services, LLC - July 13, 2015

An FDA inspection of PharMEDium Services, LLC, an outsourcing facility in Edison, NJ, was conducted from June 12 to July 13, 2015. The inspection revealed ten significant observations primarily related to Good Manufacturing Practices and compliance with specific labeling requirements for outsourcing facilities under section 503B. Main violations included a failure to thoroughly investigate unexplained discrepancies, such as environmental monitoring excursions and non-conformance events, with insufficient detail regarding root causes or product impact. Employee training for sterile processing was inadequate, with personnel operating in sterile environments despite failing gowning qualifications. The facility's control systems for preventing contamination were deficient, demonstrated by uninvestigated critical alarms from the building monitoring system, including power fluctuations and severe temperature deviations in controlled environments. Further issues encompassed improper material flow, leading to contamination risks, and an inadequate environmental monitoring program lacking daily checks in critical aseptic processing areas. There was also a lack of training for personnel inspecting finished drug products for particulate matter, and sterility testing was not performed for every batch. Additionally, batch production records and product labeling were deficient, failing to include required information such as compounding dates, inactive ingredients, and complete adverse event reporting instructions, as mandated by 503B(a)(10)(A) and (B). The company is required to implement comprehensive corrective and preventive actions to address these findings and ensure ongoing regulatory compliance.