# AGC Biologics, Inc. – FDA 483, Feb 10, 2023

Source: https://www.keypedia.com/records/483/agc-biologics-inc/642c5042-ad56-4c71-91da-5d256a20fc36

> FDA 483 for AGC Biologics, Inc. on February 10, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AGC Biologics, Inc.
- Inspection Date: 2023-02-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The FDA inspection of AGC Biologics Inc. in Bothell, WA, revealed significant deficiencies in their drug substance manufacturing. The firm failed to conduct prompt and thorough deviation investigations, lacked adequate controls for electronic data, and demonstrated insufficient measures to prevent contamination. Additionally, standard operating procedures were often not followed or were inadequate, and the quality unit exhibited poor oversight of GMP 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/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
- [483 - 2021-07-12](https://www.keypedia.com/records/483/agc-biologics-inc/532e4a4a-b139-4ca7-8e67-b3ee13096e7d) — date: July 12, 2021

## Related Officers

- [Lead Microbiologist](https://www.keypedia.com/people/brian-janelins/efd74cce-5d04-4b5b-85ff-e870df1dd30a)
- [Charles Luan-Chia Kuo, Staff Fellow](https://www.keypedia.com/people/charles-luan-chia-kuo-staff-fellow/038269f6-aa8e-46f1-bb93-a5e1ae277d6e)
- [issuing_officer](https://www.keypedia.com/people/michael-araneta/c94c95f4-2cda-43f5-a02a-2b5d82fe2c7d)
- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Teegan A. Dellibovi-ragheb](https://www.keypedia.com/people/teegan-a-dellibovi-ragheb/9a1d66fc-5b51-4001-9379-8187802307fb)

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