# FDA 483 - WuXi AppTec Inc. - May 02, 2024

Source: https://www.keypedia.com/records/483/wuxi-apptec-inc/745377ea-e96b-46ff-883f-0f7c8344fd91

> FDA 483 for WuXi AppTec Inc. on May 02, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WuXi AppTec Inc.
- Inspection Date: 2024-05-02
- Product Type: other
- Office Name: Atlanta District Office
- Summary: WuXi AppTec Inc. in Marietta, GA, a contract testing laboratory, was cited for significant deficiencies in environmental controls, aseptic processing, and quality management during an FDA inspection. Observations included inadequate cleaning and disinfection efficacy, improper labeling of human tissue sub-samples, and unvalidated in-house reagent production. The firm also failed to address environmental monitoring excursions, control humidity, and maintain equipment qualifications, indicating a systemic lack of control over critical laboratory processes.

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## Related Officers

- [Tamara A. Stephens](https://www.keypedia.com/people/tamara-a-stephens/32d1ea92-8ebd-4cd5-9c98-1e53aea35d44)
- [investigator](https://www.keypedia.com/people/leslie-w-gilbert/5c8b9e87-9563-4403-89ad-cfa3282a1ba5)

Company: https://www.keypedia.com/companies/wuxi-apptec-inc/9d289339-3edc-4d2e-aacb-4d849335e75d

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7