# FDA 483 - AGC Biologics, Inc. - March 19, 2021

Source: https://www.globalkeysolutions.net/records/483/agc-biologics-inc/81edf986-e83a-4445-85ad-bcc668cfe51e

> FDA 483 for AGC Biologics, Inc. on March 19, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC Biologics, Inc.
- Inspection Date: 2021-03-19
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of AGC Biologics Inc. in Bothell, WA, a drug substance manufacturer, revealed significant deficiencies across its manufacturing, quality control, and facility maintenance operations. Key issues included unapproved manufacturing steps, inadequate computerized system configurations, and failures in out-of-specification investigations. The firm also exhibited poor documentation practices, unaddressed equipment repairs, and inadequate validations, indicating a lack of robust quality systems and control over critical processes.

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## Related Officers

- [Nathaniel B. Phillips-Sylvain](https://www.globalkeysolutions.net/people/nathaniel-b-phillips-sylvain/34a64fcb-7add-4aad-a507-4af7e2b4cf9b)
- [Christopher P. Czajka](https://www.globalkeysolutions.net/people/christopher-p-czajka/fac75f0a-df9b-4d47-aeec-c3937b4e790b)
- [investigator](https://www.globalkeysolutions.net/people/riley-myers/22266738-1313-45db-902d-eaf4c63d4131)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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

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