# FDA 483 - Juzen Chemical Corporation - August 01, 2025

Source: https://www.globalkeysolutions.net/records/483/juzen-chemical-corporation/89034937-623c-4059-8a28-407d8076e47e

> FDA 483 for Juzen Chemical Corporation on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Juzen Chemical Corporation
- Inspection Date: 2025-08-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Juzen Chemical Corporation, an API manufacturer in Toyama, Japan, revealed significant issues with their manufacturing processes. The firm lacked a scientifically sound cleaning validation program and failed to adequately evaluate their water system for objectionable microorganisms. These observations indicate potential risks to product quality and safety.

## Related Documents

- [483 - 2018-03-09](https://www.globalkeysolutions.net/records/483/juzen-chemical-corporation/6edb6943-4133-4f7f-b01b-aa10f70020bb)

## Related Officers

- [ Drug Investigator](https://www.globalkeysolutions.net/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

Company: https://www.globalkeysolutions.net/companies/juzen-chemical-corporation/f0144252-c4b5-4348-8215-996006285286

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