# FDA 483 - Wuxi Apptec Suzhou Co.,Ltd - Unknown Date

Source: https://www.keypedia.com/records/483/wuxi-apptec-suzhou-coltd/e7bbaa02-9922-4374-8fa0-ca7c33448c33

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

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## Details

- Record Type: 483
- Company Name: Wuxi Apptec Suzhou Co.,Ltd
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: WuXi AppTec, a nonclinical laboratory in Suzhou, China, was inspected by the FDA, resulting in two observations. The inspection revealed issues with facility maintenance, including peeled paint and corrosion on HEPA filter covers in several laboratory rooms. Additionally, the quality assurance unit failed to ensure proper documentation of deviations, specifically regarding unlabeled bedding materials in storage.

## Related Documents

- [483 - 2019-03-08](https://www.keypedia.com/records/483/wuxi-apptec-suzhou-coltd/5bf01d8e-8c71-4a0c-8766-d5644fef55d7)

## Related Officers

- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)
- [Andrew R. Wasko](https://www.keypedia.com/people/andrew-r-wasko/87f194a2-d86b-4dad-8319-07f107ad8e6a)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd