483
Bioreliance Ltd.Bioreliance Ltd. – FDA 483, Dec 5, 2025
Record Details
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.
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ID · c87e74bb-34fe-4329-aab5-9c578962c664
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