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

Source: https://www.globalkeysolutions.net/records/483/covance-pharmaceutical-rd-shanghai-co-ltd/2c13fe15-1634-494a-9012-2733726731f7

> FDA 483 for Covance Pharmaceutical R&D (Shanghai) Co., Ltd. on July 20, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covance Pharmaceutical R&D (Shanghai) Co., Ltd.
- Inspection Date: 2015-07-20
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)
- [Stuart W. Russell](https://www.globalkeysolutions.net/people/stuart-w-russell/59719ee0-e7b3-4e10-8d87-7c79eb2c2192)

Company: https://www.globalkeysolutions.net/companies/covance-pharmaceutical-rd-shanghai-co-ltd/c3293645-b933-42a3-8a29-9ea6ce45d52d

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321