# FDA 483 - Tokyo Chemical Industry Co Ltd - May 16, 2025

Source: https://www.keypedia.com/records/483/tokyo-chemical-industry-co-ltd/3079e976-91f3-4144-9070-4be3427b0075

> FDA 483 for Tokyo Chemical Industry Co Ltd on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tokyo Chemical Industry Co Ltd
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Tokyo Chemical Industry Co., Ltd. in Fukaya, Japan, a human API manufacturer, revealed significant deficiencies in laboratory control and quality systems. The firm failed to thoroughly investigate out-of-specification results, deviations, and customer complaints, lacking scientific evidence and proper documentation. Additionally, stability storage conditions for API samples were not consistently maintained, raising concerns about product quality and integrity.

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- [483 - 2018-10-15](https://www.keypedia.com/records/483/tokyo-chemical-industry-co-ltd/663c458e-31e1-496a-8413-c8f56324659d)

## Related Officers

- [Monica E. Murie](https://www.keypedia.com/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)

Company: https://www.keypedia.com/companies/tokyo-chemical-industry-co-ltd/777f1c4a-29f8-48cc-9a51-dc89b896f327

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