# FDA 483 - AGC, Inc. - October 27, 2023

Source: https://www.keypedia.com/records/483/agc-inc/e0d2ff65-cd21-4d8b-9184-d5c67694dfcf

> FDA 483 for AGC, Inc. on October 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC, Inc.
- Inspection Date: 2023-10-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: AGC Inc. in Ichihara-shi, Chiba, Japan, an API manufacturer, received a Form FDA 483 with three observations. The inspection revealed significant issues with the firm's quality unit, including inadequate analytical procedures, sampling, and specifications for raw materials and finished APIs. Additionally, the firm failed to adequately investigate deviations related to environmental monitoring and out-of-specification results, and lacked proper control over its label storage and printing system.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

Company: https://www.keypedia.com/companies/agc-inc/884872af-3dff-4a81-9409-2e77de6f14ba

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1