483
AGC Biologics, Inc.AGC Biologics, Inc. – FDA 483, Mar 27, 2024
Record Details
An FDA inspection of AGC Biologics in Bothell, WA, a drug substance manufacturer, revealed significant deficiencies across multiple areas. The firm was cited for inadequate and un-followed Standard Operating Procedures, failure to maintain sterility of tools during bulk filling, and insufficient analytical method validation, including repeat observations from a previous inspection. Additionally, equipment maintenance was found to be inadequate.
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ID · 1ae2bd69-95b9-4aa9-8673-4ed83ff4a444
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