U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

Quality Certificates

WuXi AppTec’s corporate commitment to quality is reflected in the quality programs/systems at its U.S. sites located in St. Paul, Minnesota; Atlanta, Georgia; and Philadelphia, Pennsylvania.

A “Regulatory & Quality Overview” booklet is available that provides detailed information on the U.S. sites. The booklet can be used to answer most, if not all, of the questions traditionally included in a standard quality questionnaire and serve as a starting point for further discussions or as basic information prior to auditing. To request a copy, contact the QA director at any one of the U.S. facilities or email: info@wuxiapptec.com.

For the convenience of our clients, we are also pleased to make available the following PDFs of accreditation/registration certificates for viewing or downloading.

Accreditation / Registrations

Food and Drug Administration (FDA) Drug Establishments Registration

Note: The U.S. Food and Drug Administration (FDA) does not issue hardcopy certificates for Drug Establishments Registration. The link above is to a PDF (screen capture) of the FDA website page that verifies the Drug Establishments Current Registration for WuXi AppTec U.S. facilities.

St. Paul, Minnesota

Atlanta, Georgia

Philadelphia, Pennsylvania