# AGC Biologics, Inc. – FDA 483

Source: https://www.keypedia.com/records/483/agc-biologics-inc/68b9608f-4ced-445d-97ca-dbe85c33ee88

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

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## Details

- Record Type: 483
- Company Name: AGC Biologics, Inc.
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: CMC ICOS Biologics, Inc. in Bothell, Washington, was inspected by the FDA, revealing significant deficiencies in their manufacturing processes. The inspection found incomplete process validation, inadequate investigation of production deviations, and failures in performing preventative maintenance and following deviation management procedures. These issues indicate a lack of control over critical manufacturing operations.

## Related Documents

- [483 - 2025-04-18](https://www.keypedia.com/records/483/agc-biologics-inc/5feb9b19-4203-4a42-8153-4c5ad2c4aa43) — date: April 18, 2025
- [483 - 2024-03-27](https://www.keypedia.com/records/483/agc-biologics-inc/1ae2bd69-95b9-4aa9-8673-4ed83ff4a444) — date: March 27, 2024
- [483 - 2023-02-10](https://www.keypedia.com/records/483/agc-biologics-inc/642c5042-ad56-4c71-91da-5d256a20fc36) — date: February 10, 2023
- [483 - 2023-02-10](https://www.keypedia.com/records/483/agc-biologics-inc/29068fb0-b901-4b27-8d6c-480f07b9d85d) — date: February 10, 2023
- [EIR - 2021-07-23](https://www.keypedia.com/records/eir/agc-biologics-inc/018c23f4-6b30-46f0-a167-ffc910d3fe5a) — date: July 23, 2021

## Related Officers

- [Lori A. Walderhaug, LDR](https://www.keypedia.com/people/lori-a-walderhaug-ldr/1c3598c9-7c8f-4e87-95a9-0266cb8f7c95)
- [Biologist](https://www.keypedia.com/people/michael-s-swanson/0a1ac893-4932-4620-be91-5d5e9e554e49)
- [VP, Solutions at Lindus Health](https://www.keypedia.com/people/vanessa-gelsey/dadef4ec-1948-4789-81cb-1c5b9e117f8e)
- [Lead Biologist](https://www.keypedia.com/people/jin-sung-hong/c1442e69-a994-4b70-8666-8b77485f63c7)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4