FDA 483 - WuXi AppTec, Inc. - September 10, 2019
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The FDA inspection of WuXi AppTec, Inc's nonclinical laboratory in Saint Paul, MN, revealed numerous and systemic deficiencies in adherence to Good Laboratory Practices (GLP). Observations included inadequate labeling of test articles, premature discarding of specimens, poor archive management, and failures in data integrity and protocol adherence across many GLP studies. The quality assurance unit also failed to identify these widespread non-conformances, indicating a significant breakdown in the firm's GLP compliance.
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