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

Source: https://www.keypedia.com/records/483/agc-inc/070c95b7-8d1c-4d76-9e6c-3ebd1015d681

> 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
- Summary: The FDA conducted an inspection of AGC Inc., an Active Pharmaceutical Ingredient (API) manufacturer in Ichihara-shi, Chiba, Japan, from October 23-27, 2023. The inspection resulted in a Form FDA 483, detailing significant observations related to the company's quality and labeling systems, indicating potential non-compliance with Current Good Manufacturing Practices. Key issues identified included deficiencies in the quality unit's oversight of analytical procedures. Specifically, the firm lacked scientific justification for sampling and testing methods for insoluble particulate matter and viable bacteria, including an inadequate plate count method that could misrepresent microbial levels. The titration assay for an intermediary product was also noted as not robust or repeatable, leading to out-of-specification results. Furthermore, the company failed to test finished APIs for Burkholderia cepacia complex organisms without scientific justification. The inspection also revealed inadequate investigation and follow-up for deviations. The company did not properly assess the impact on products from mold and bacteria found above action levels in clean and adjacent production areas. Investigations into out-of-specification particulate matter results were insufficient, lacking documentation and verification of filter effectiveness. Lastly, the labeling system was found to have uncontrolled access, allowing manufacturing personnel to print and edit labels, and the Excel-based system lacked validation for access control. AGC Inc. is required to provide a comprehensive response detailing corrective actions to address these serious observations.

## Related Documents

- [483 - 2023-10-27](https://www.keypedia.com/records/483/agc-inc/e0d2ff65-cd21-4d8b-9184-d5c67694dfcf)

## Related Officers

- [Bobbi Jo Williams](https://www.keypedia.com/people/bobbi-jo-williams/86eaea2e-a99f-4c3b-b83c-6b0d7effca3f)

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