# FDA 483 - Fujimoto Chemicals Co., Ltd., Kinraku Plant - February 01, 2024

Source: https://www.keypedia.com/records/483/fujimoto-chemicals-co-ltd-kinraku-plant/c76aaf74-1bcf-4164-9c71-89a4d4b47955

> FDA 483 for Fujimoto Chemicals Co., Ltd., Kinraku Plant on February 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fujimoto Chemicals Co., Ltd., Kinraku Plant
- Inspection Date: 2024-02-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Fujimoto Chemicals Co., Ltd., Kinraku Plant in Hyogo, Japan, a manufacturer of drug substances, revealed significant deficiencies in their quality control systems. Observations included inadequate laboratory test procedures for related substances and microbiological examination, a risk of contamination in the water system due to dead legs, and a failure to visually examine reserve samples for deterioration. These findings indicate a need for comprehensive improvements in their manufacturing and control processes.

## Related Officers

- [Dennis Cantellops Paite](https://www.keypedia.com/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)

Company: https://www.keypedia.com/companies/fujimoto-chemicals-co-ltd-kinraku-plant/8c876edf-5d3a-4ef2-8647-c145fc72d5ca

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1