# FDA 483 - AGC Biologics, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/agc-biologics-inc/361f2f05-4042-44c5-985a-e95863e25cc0

> FDA 483 for AGC Biologics, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC Biologics, Inc.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

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## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Richard Ledwidge, Ph.D., Biologist](https://www.keypedia.com/people/richard-ledwidge-phd-biologist/51161c1e-63da-4f24-bf8b-ecc1398c9dbe)
- [Kathryn King, Lead Biologist](https://www.keypedia.com/people/kathryn-king-lead-biologist/d0f3c047-649a-412b-aa2f-d4de2c3bd3b1)

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