WuXi AppTec, Inc. – FDA 483, Sep 10, 2019
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.
ID · eb8aae0f-dacb-452c-80a5-4476a99cc4ce
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.