FDA 483 - WuXi Advanced Therapies - April 17, 2015

An FDA inspection of WuXi AppTec, Inc. in Philadelphia, PA, a control laboratory, revealed significant deficiencies in its quality control unit, including incomplete reviews for test result release, lack of assurance for analyst training, and inadequate review of discrepancies. The inspection also cited the firm for failing to justify deviations from written test procedures and for maintaining incomplete laboratory records that lacked essential instrument identification and traceable raw data. These observations indicate a need for improved adherence to established quality and documentation practices.