FDA 483 - Bioreliance Ltd. - December 05, 2025

Bioreliance Ltd. in Glasgow, a drug substance manufacturer, received a Form 483 citing three significant observations. The firm failed to adequately investigate out-of-specification bioburden test results for an Adenovirus Type 7 batch, which was released to the U.S. market. Additionally, deficiencies were noted in material storage, inventory control, and aseptic practices during bulk filling operations.