AGC Biologics hit with 483 for poor discrepancy investigation practices, quality control issues at Washington site
CDMO ACG Biologics received an FDA 483 letter, published on the FDA website this week, noting one of its sites failed to conduct proper investigations into discrepancies, lack of quality control over manufacturing and lack of assurance to prevent contamination.
The 15-page letter was written after a five-day inspection in February 2023 at a site in Bothell, WA, which is designed for mammalian and microbial fermentation manufacturing, process development and R&D.
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