Sumitomo Chemical Co., Ltd.September 20, 2016

FDA 483 - Sumitomo Chemical Co., Ltd. - September 20, 2016

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 Sumitomo Chemical Co., Ltd.

Record Details

An FDA inspection of Sumitomo Chemical Co., Ltd. in Anpachi-cho, Gifu, Japan, an API manufacturer, revealed significant deficiencies in laboratory controls and document management. The firm failed to conduct proper investigations into unexplained laboratory discrepancies and did not retain raw data calculations. Additionally, the Quality unit exhibited inadequate control over the issuance of master production records.

Company: Sumitomo Chemical Co., Ltd.
Inspection Date: September 20, 2016
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Lindsey M. Schwinghamm

Open in Dashboard

ID · f014e97b-7130-4bc3-9a39-bd4194367cbf