FDA 483 - Bio Products Laboratory Ltd - August 30, 2022

During an inspection conducted from August 22-30, 2022, Bio Products Laboratory Ltd. in Elstree, UK, received an FDA Form 483 detailing significant deviations from regulatory requirements for plasma fractionation and finished drug manufacturing. Key observations included the company's failure to adequately investigate customer complaints of visible particles in Zenalb 20% by extending inquiries to associated drug products like Albuminex. The FDA also cited delays in reporting Biological Product Deviation Reports, with some taking over 80 days to report instead of the required 45. Repeated observations highlighted severe deficiencies in aseptic processing, where procedures designed to prevent microbiological contamination were not followed. Inspectors noted improper operator movements, insufficient glove sanitization, and unvalidated disinfection methods in critical areas, leading to multiple microbial excursions. Environmental monitoring systems were found inadequate, with concerns regarding sampling locations and documentation. Furthermore, the company failed to record deviations for aborted batches and lacked validation for critical test methods, including sterility testing for sterile Water for Injection and endotoxin testing for Gammaplex. Established test procedures for products like Coagadex were also not consistently followed. These issues necessitate comprehensive corrective actions to ensure product quality, purity, and patient safety.