FDA 483 - AGC Biologics, Inc. - March 27, 2024

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.