AGC Biologics, Inc.March 27, 2024

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

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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.

Company: AGC Biologics, Inc.
Inspection Date: March 27, 2024
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Ian L. McWilliams
Mercy Oyugi
Jiangping Jiang
Michael R. Shanks (Investigator)
Jeanne M. Fringer (other)

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ID · 1ae2bd69-95b9-4aa9-8673-4ed83ff4a444