# FDA 483 - Xenobiotic Laboratories, Inc. - March 28, 2025

Source: https://www.globalkeysolutions.net/records/483/xenobiotic-laboratories-inc/012beef3-6a9b-4160-a875-de557d6acfeb

> FDA 483 for Xenobiotic Laboratories, Inc. on March 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xenobiotic Laboratories, Inc.
- Inspection Date: 2025-03-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of WuXi AppTec Co., Ltd. (doing business as Xenobiotic Laboratories) in Plainsboro, NJ, revealed a significant issue regarding the firm's adherence to its Standard Operating Procedures (SOPs) for reinjection of analytical runs. Specifically, the firm failed to follow established protocols for reinjecting samples during method validation and study sample analysis, leading to the improper reinjection of entire runs instead of specific missed or failing samples. This indicates a deviation from internal quality control procedures in a biopharmaceutical analytical facility.

## Related Officers

- [Yi-Ying Chen, MSc., M.S.R.A](https://www.globalkeysolutions.net/people/yi-ying-chen-msc-msra/52603e8a-0bec-4be9-b1f5-f0f6ea2c5fb0)
- [Yiying E. Chen](https://www.globalkeysolutions.net/people/yiying-e-chen/1fcf176f-3d89-45e3-8859-64f614cf14b3)

Company: https://www.globalkeysolutions.net/companies/xenobiotic-laboratories-inc/c0d04e2b-594e-4cff-8d47-656e002c4ce6

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248