FDA 483 - AGC Biologics, Inc.

An FDA inspection of AGC Biologics, a drug substance manufacturing facility in Bothell, WA, revealed six significant observations. The firm was cited for operating a harvest filtration unit in an unvalidated state and conducting incomplete root cause investigations for various process deviations. Additionally, the inspection found inadequate microbial control during manufacturing, insufficient quality assurance oversight, inconsistencies between SOPs and batch records, and a failure to follow approved validation protocols.