Covance Pharmaceutical R&D (Shanghai) Co., Ltd.July 20, 2015

FDA 483 - Covance Pharmaceutical R&D (Shanghai) Co., Ltd. - July 20, 2015

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 Covance Pharmaceutical R&D (Shanghai) Co., Ltd.

Record Details

Covance Pharmaceutical R&D (Shanghai) Co., Ltd., a non-clinical laboratory, received two observations during an FDA inspection. The firm was cited for failing to provide separate areas to prevent contamination and mix-ups of test and control articles. Additionally, the inspection found that equipment, specifically a water purification device, was not adequately inspected, cleaned, and maintained according to the firm's own standard operating procedures.

Company: Covance Pharmaceutical R&D (Shanghai) Co., Ltd.
Inspection Date: July 20, 2015
Product Type: Drugs
Office: International Compliance Team
People: Zhou Chen (issuing_officer)
Stuart W. Russell

Open in Dashboard

ID · 2c13fe15-1634-494a-9012-2733726731f7