# FDA 483 - Fujimoto Chemicals Co., Ltd. - May 12, 2023

Source: https://www.keypedia.com/records/483/fujimoto-chemicals-co-ltd/bf42527f-9a0d-4d4f-bcb5-8b5029d54f96

> FDA 483 for Fujimoto Chemicals Co., Ltd. on May 12, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fujimoto Chemicals Co., Ltd.
- Inspection Date: 2023-05-12
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Fujimoto Chemicals Co., Ltd. (Senboku Plant), an Active Pharmaceutical Ingredient (API) manufacturer in Izumiotsu, Osaka, was cited for deficiencies in establishing the reliability of component suppliers. The inspection revealed issues with verifying certificates of analyses for raw ingredients and a lack of current supplier audits for critical suppliers, with unverified corrective actions for major findings.

## Related Documents

- [483 - 2023-05-12](https://www.keypedia.com/records/483/fujimoto-chemicals-co-ltd/dc2540a3-a02c-4d20-9d1e-5e150834de78)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.keypedia.com/companies/fujimoto-chemicals-co-ltd/5eb30b5e-11f7-4f61-9d9d-eb846580d0e0

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c