# AGC WAKASA CHEMICALS CO., LTD. – FDA 483, Aug 21, 2026

Source: https://www.keypedia.com/records/483/agc-wakasa-chemicals-co-ltd/96649359-b32b-4a7b-ac0c-93b7e1f38cc4

> FDA 483 for AGC WAKASA CHEMICALS CO., LTD. on August 21, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC WAKASA CHEMICALS CO., LTD.
- Inspection Date: 2026-08-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: During an inspection, AGC Wakasa Chemicals Co., Ltd, an API and Intermediate Manufacturer in Obama, Fukui, Japan, was cited for significant quality control deficiencies. Observations included inadequate investigation and follow-up for out-of-specification and deviation test results, with instances of retesting lacking scientific justification. Additionally, the firm failed to requalify the HVAC system and perform temperature mapping for a critical clean room used for API filling since its construction in 2012.

## Related Documents

- [483 - 2023-11-02](https://www.keypedia.com/records/483/agc-wakasa-chemicals-co-ltd/357ea66d-1020-486f-a736-14f9485e2994) — date: November 2, 2023

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)

Company: https://www.keypedia.com/companies/agc-wakasa-chemicals-co-ltd/ae23f1a3-a386-4439-b25f-bc628a58475e

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8