# FDA 483 - WuXi AppTec, Inc. - September 10, 2019

Source: https://www.keypedia.com/records/483/wuxi-apptec-inc/eb8aae0f-dacb-452c-80a5-4476a99cc4ce

> FDA 483 for WuXi AppTec, Inc. on September 10, 2019. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: WuXi AppTec, Inc.
- Inspection Date: 2019-09-10
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Documents

- [483 - 2015-04-13](https://www.keypedia.com/records/483/wuxi-apptec-inc/ff224cc5-56a5-47dc-8029-f9422c39ca3a)

## Related Officers

- [investigator](https://www.keypedia.com/people/nicole-c-victoria/8c5f8060-452f-4fe5-a43f-a448ec020e60)

Company: https://www.keypedia.com/companies/wuxi-apptec-inc/5a415856-23a1-4f69-a085-cda0d9ae9ca3

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d