# Nippon Kayaku Pharmatech Co., Ltd. – FDA 483, Sep 4, 2026

Source: https://www.keypedia.com/records/483/nippon-kayaku-pharmatech-co-ltd/60801a44-3868-42f1-9f09-f58cc11cbdce

> FDA 483 for Nippon Kayaku Pharmatech Co., Ltd. on September 04, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nippon Kayaku Pharmatech Co., Ltd.
- Inspection Date: 2026-09-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Fuji Yakuhin Co., Ltd. in Toyama, Japan, a sterile drug manufacturing facility, was cited for multiple deficiencies during an FDA inspection. The observations highlight significant failures in following aseptic processing procedures, inadequate validation of aseptic processes, and incomplete equipment cleaning and sanitization. Additionally, the firm's quality control laboratory was found to have issues with data integrity related to chromatographic analysis.

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## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/nippon-kayaku-pharmatech-co-ltd/88530942-e172-4a65-8c32-4495fdaa6b61

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