Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical – FDA 483, Dec 20, 2019

An FDA inspection conducted from December 2 to December 20, 2019, at Fusion IV Pharmaceuticals, Inc. (dba Axia Pharmaceutical), a producer of sterile drug products, revealed significant violations of current Good Manufacturing Practices (CGMP). The observations highlighted critical deficiencies across various operational areas. Key issues included inadequately maintained facilities, such as yellow staining and peeling tape in aseptic laminar flow workstations. The company failed to follow proper procedures to prevent microbiological contamination, including poor aseptic techniques, lack of routine hand sanitization, and insufficient investigation into multiple media fill sterility failures, some of which were repeat observations from a prior inspection. Furthermore, not all media vials from aseptic process simulations were incubated. The firm demonstrated a failure to thoroughly investigate unexplained discrepancies and out-of-specification results. Notably, several drug product batches with initial sterility failures were invalidated without adequate justification, and some were inadvertently distributed. Employee training for critical quality control, visual inspection, and labeling operations was found to be lacking documented evidence. Laboratory controls were deficient, with insufficient growth promotion testing for media and a complete absence of antimicrobial effectiveness studies for preservative-containing products, a repeat observation. Manual visual inspection for product contamination was deemed inadequate, including improper handling of dropped vials. The quality control unit lacked the necessary authority to fully investigate positive sterility results and customer complaints, some of which involved serious adverse events like sepsis, without proper reporting to the FDA. Environmental monitoring systems were also found to be deficient, with undocumented pressure differential reviews, uninvestigated action limit excursions, and missed monitoring schedules. Finally, documentation for packaging and labeling materials was inadequate, leading to potential mix-ups, and method suitability for sterility and endotoxin testing was incomplete. Fusion IV Pharmaceuticals is required to implement comprehensive corrective actions to address these serious deviations and ensure compliance with CGMP regulations for sterile drug manufacturing.