WuXi AppTec’s corporate commitment to quality is reflected in the quality programs/systems at its three 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.

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 all three WuXi AppTec U.S. facilities.

ST. PAUL, MINNESOTA

• American Association of Tissue Banks (AATB)
• American Association for Laboratory Accreditation: Certificate of Accreditation – ISO/IEC 17025:2005
• BSI Certificate of Registration: Quality Management System – ISO 13485:2003
• EMA Certificate of GMP Compliance
• Food and Drug Administration (FDA) Establishment Registration and Listing for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps)
• State of California Tissue Bank License
• State of Florida Tissue Bank Certificate
• State of Maryland Tissue Bank Permit
• State of New York Provisional License for Tissue Banks

ATLANTA, GEORGIA

• American Association for Laboratory Accreditation: Certificate of Accreditation – ISO/IEC 17025:2005
• Food and Drug Administration (FDA) Establishment Registration and Listing for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps)

PHILADELPHIA, PENNSYLVANIA

• American Association for Laboratory Accreditation: Certificate of Accreditation - ISO/IEC 17025:2005
• EMA Certificate of GMP Compliance
• Food and Drug Administration (FDA) Establishment Registration and Listing for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps)