# FDA 483 - Wuxi Apptec Suzhou Co.,Ltd - March 08, 2019

Source: https://www.keypedia.com/records/483/wuxi-apptec-suzhou-coltd/5bf01d8e-8c71-4a0c-8766-d5644fef55d7

> FDA 483 for Wuxi Apptec Suzhou Co.,Ltd on March 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi Apptec Suzhou Co.,Ltd
- Inspection Date: 2019-03-08
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: During an inspection of WuXi AppTec (Suzhou) Co., Ltd., a nonclinical laboratory, the FDA observed two significant issues. The firm failed to test the uniformity of test article mixtures and its quality assurance unit did not properly determine whether deviations from approved protocols were authorized and documented. These observations indicate deficiencies in study conduct and quality oversight.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/wuxi-apptec-suzhou-coltd/e7bbaa02-9922-4374-8fa0-ca7c33448c33)

## Related Officers

- [Marijo B. Kambere](https://www.keypedia.com/people/marijo-b-kambere/54e010f0-0d56-4b20-b5e2-112e372de58b)
- [Joanne M. Schlossin](https://www.keypedia.com/people/joanne-m-schlossin/5cb48b8a-d885-4b4f-8c60-d4714d65603d)
- [issuing_officer](https://www.keypedia.com/people/mark-j-seaton/640c2deb-25ff-4e2e-8f48-d15d31f9c5bf)
- [Zhen (Jane) Luo](https://www.keypedia.com/people/zhen-jane-luo/d0cb26a2-a81f-44b4-88b5-5d2e6b8394c7)

Company: https://www.keypedia.com/companies/wuxi-apptec-suzhou-coltd/960223af-2d10-4301-9925-cdbedc5d2eaf

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321