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

Source: https://www.keypedia.com/records/483/agc-biologics-inc/1ae2bd69-95b9-4aa9-8673-4ed83ff4a444

> FDA 483 for AGC Biologics, Inc. on March 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC Biologics, Inc.
- Inspection Date: 2024-03-27
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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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## Related Officers

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- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/agc-biologics-inc/9759f733-dd5f-4f2e-a516-f1b37fad39e2

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd