WuXi AppTec Lab Testing Division’s Analytical and Stability Testing Facilities Passed FDA Inspection
Apr 11, 2016
Shanghai, April 11, 2016 – WuXi AppTec (WuXi), a leading open-access R&D capability and technology platform company serving the global pharmaceutical, biotechnology and medical device industries, today announced that WuXi Lab Testing Division (LTD)’s late-and commercial-stage analytical and stability testing facilities in Shanghai successfully passed an FDA inspection for GMP compliance.
The inspector from FDA China office evaluated WuXi LTD’s quality system during a 4-day inspection, with focus on data integrity and compliance across its GMP analytical and stability testing facilities. The inspection outcome confirmed WuXi’s adherence to FDA’s rigorous GMP guidance and its high quality of operation.
“FDA expects the highest quality and data integrity, and we are proud to receive a very positive feedback, ”said Dr. Ge Li, Chairman and CEO of WuXi AppTec, “ We will continue to uphold the highest quality standards and provide best-in-class R&D services for our customers worldwide.”
About WuXi AppTec
WuXi AppTec is a leading pharmaceutical, biotechnology, and medical device R&D platform company with global operations. As a research-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi AppTec's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. WuXi AppTec is also building a platform to provide clinical diagnostic services directly to physicians and their patients globally. Please visit: http://www.wuxiapptec.com.
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