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

Source: https://www.keypedia.com/records/483/fujimoto-chemicals-co-ltd/dc2540a3-a02c-4d20-9d1e-5e150834de78

> 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: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Fujimoto Chemicals Co., Ltd.'s Senboku Plant, an Active Pharmaceutical Ingredient (API) manufacturer in Izumiotsu, Osaka, revealed significant deficiencies in their supplier management program. The firm failed to adequately validate supplier reports of analyses for raw ingredients and did not perform required audits for critical suppliers, leaving major findings unverified. These issues indicate a lack of robust quality control over incoming materials.

## 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/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1