Otsuka Pharmaceutical Co., Ltd.July 7, 2025

FDA 483 - Otsuka Pharmaceutical Co., Ltd. - July 07, 2025

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 Otsuka Pharmaceutical Co., Ltd.

Record Details

An FDA inspection of Otsuka Pharmaceutical Co., Ltd. in Kanzaki-Gun, Saga, Japan, revealed significant deficiencies in their API manufacturing processes. The firm failed to ensure that test methods and specifications for a critical (b)(4) API reference standard were scientifically sound and appropriately validated. This included a lack of validation for the in-house reference standard and insufficient quality oversight during its manufacturing.

Company: Otsuka Pharmaceutical Co., Ltd.
Inspection Date: July 7, 2025
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Marian E. Ramirez (investigator)

Open in Dashboard

ID · 65d3e912-60d3-4e10-ae9a-58f2210264b1