Fuji Yakuhin Co., Ltd.November 26, 2019

FDA 483 - Fuji Yakuhin Co., Ltd. - November 26, 2019

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Fuji Yakuhin Co., Ltd.

Record Details

An FDA inspection of Fuji Yakuhin Co., Ltd. in Toyama-shi, Japan, a manufacturer of sterile drug products, revealed significant deficiencies. Observations included inadequate aseptic process validation, insufficient disinfectant efficacy studies, and critical issues with electronic record integrity and retention. Additionally, the firm failed to adequately qualify suppliers for container and closure components.

Company: Fuji Yakuhin Co., Ltd.
Inspection Date: November 26, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Darren S. Brown (Consumer Safety Officer)

Open in Dashboard

ID · 15f40bdb-099d-4908-9b4f-1e6bfc4e13f9