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

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

- [EIR - 2018-10-15](https://www.keypedia.com/records/eir/agc-biologics-inc/c948abe0-9dc6-4233-aa13-d23bdfc0fa4b)
- [EIR - 2012-04-18](https://www.keypedia.com/records/eir/agc-biologics-inc/52119d90-5826-4ae3-b91b-7ee6b9f06655)
- [483 - 2023-02-10](https://www.keypedia.com/records/483/agc-biologics-inc/642c5042-ad56-4c71-91da-5d256a20fc36)
- [483 - 2021-03-19](https://www.keypedia.com/records/483/agc-biologics-inc/81edf986-e83a-4445-85ad-bcc668cfe51e)
- [483 - 2025-04-18](https://www.keypedia.com/records/483/agc-biologics-inc/5feb9b19-4203-4a42-8153-4c5ad2c4aa43)

## Related Officers

- [Lori A. Walderhaug, LDR](https://www.keypedia.com/people/lori-a-walderhaug-ldr/1c3598c9-7c8f-4e87-95a9-0266cb8f7c95)
- [Michael S. Swanson, CBER BIOLOGIST](https://www.keypedia.com/people/michael-s-swanson-cber-biologist/0a1ac893-4932-4620-be91-5d5e9e554e49)
- [Jin Sung Hong, CBER Fellow](https://www.keypedia.com/people/jin-sung-hong-cber-fellow/94f22fb9-166b-418f-b257-6e2d0b029ad0)
- [Vanessa V. Godsey, Investigator](https://www.keypedia.com/people/vanessa-v-godsey-investigator/abd17ca1-6600-4cc5-9d86-545853a12d3a)

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