# FDA 483 - AGC Biologics, Inc. - July 12, 2021

Source: https://www.keypedia.com/records/483/agc-biologics-inc/532e4a4a-b139-4ca7-8e67-b3ee13096e7d

> FDA 483 for AGC Biologics, Inc. on July 12, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC Biologics, Inc.
- Inspection Date: 2021-07-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of AGC Biologics, Inc. in Bothell, WA, revealed significant deficiencies across three observations. The firm failed to consistently follow and maintain effective sanitization procedures, leading to fungal contamination trends. Additionally, investigations into unexplained discrepancies and batch failures were found to be incomplete, lacking definitive root causes and adequate follow-up actions.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822