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

Source: https://www.keypedia.com/records/483/agc-biologics-inc/f364fb7c-8e0e-47cb-905e-2ec30672b2c1

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

---

## Details

- Record Type: 483
- Company Name: AGC Biologics, Inc.
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: ICMC Biologics, Inc, dba AGC Biologics in Bothell, WA, received a Form 483 with four observations following an FDA inspection from October 4-15, 2018. The inspection revealed significant deficiencies in contamination control, facility maintenance, corrective action procedures, and electronic record integrity. These issues indicate a lack of robust quality systems and controls in critical manufacturing and data management areas.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/agc-biologics-inc/361f2f05-4042-44c5-985a-e95863e25cc0)
- [EIR - 2021-03-19](https://www.keypedia.com/records/eir/agc-biologics-inc/7a3e7ea1-7f89-4fff-9f88-dade096c5e9f)
- [483 - 2025-04-18](https://www.keypedia.com/records/483/agc-biologics-inc/5feb9b19-4203-4a42-8153-4c5ad2c4aa43)
- [483 - 2023-02-10](https://www.keypedia.com/records/483/agc-biologics-inc/29068fb0-b901-4b27-8d6c-480f07b9d85d)
- [483 - 2023-02-10](https://www.keypedia.com/records/483/agc-biologics-inc/642c5042-ad56-4c71-91da-5d256a20fc36)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/arie-c-menachem/01bacbef-a3ae-4eb0-a56f-e8a70b67a524)

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