Fujimoto Chemicals Co., Ltd.May 12, 2023

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

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 Fujimoto Chemicals Co., Ltd.

Record Details

Fujimoto Chemicals Co., Ltd. (Senboku Plant), an Active Pharmaceutical Ingredient (API) manufacturer in Izumiotsu, Osaka, was cited for deficiencies in establishing the reliability of component suppliers. The inspection revealed issues with verifying certificates of analyses for raw ingredients and a lack of current supplier audits for critical suppliers, with unverified corrective actions for major findings.

Company: Fujimoto Chemicals Co., Ltd.
Inspection Date: May 12, 2023
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Saundrea A. Munroe (Drug Specialist / Drug Investigator)

Open in Dashboard

ID · bf42527f-9a0d-4d4f-bcb5-8b5029d54f96