FDA 483 - Bioreliance Ltd. - December 05, 2025

Bioreliance Ltd. in Glasgow, United Kingdom, a drug substance manufacturer and control testing laboratory, was cited for three significant observations during an FDA inspection. The firm failed to adequately investigate out-of-specification bioburden test results for Adenovirus Type 7, demonstrating deficiencies in scope, testing methodology, risk assessment, and OOS invalidation. Additionally, the inspection revealed inadequate procedures for the storage, identification, tracking, and segregation of manufacturing materials, compromising traceability and inventory accuracy, and deficient aseptic practices were observed in a Biological Safety Cabinet, coupled with insufficient training procedures for employees.