Sumika Chemical Analysis Service, Ltd.November 13, 2019

FDA 483 - Sumika Chemical Analysis Service, Ltd. - November 13, 2019

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Record Details

An FDA inspection of Sumika Chemical Analysis Service, Ltd., a contract testing laboratory in Oita, Japan, revealed a critical data integrity issue. The firm failed to ensure that backup data from stand-alone analytical instruments was secure from alteration, erasure, or loss. This deficiency impacts the reliability of testing data for various APIs and drug products supplied to the US market.

Company: Sumika Chemical Analysis Service, Ltd.
Inspection Date: November 13, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Sangeeta M. Khurana (Consumer Safety Officer)

Open in Dashboard

ID · e076b85e-9fa6-41c7-ac5b-55fe37a759c0