# FDA 483 - Qiagen Sciences LLC - July 16, 2021

Source: https://www.globalkeysolutions.net/records/483/qiagen-sciences-llc/c79300a6-193b-4258-9bdb-8ec24a4c743f

> FDA 483 for Qiagen Sciences LLC on July 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qiagen Sciences LLC
- Inspection Date: 2021-07-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Qiagen Sciences LLC in Germantown, MD, from July 12-16, 2021, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The firm's CAPA process failed to consistently require corrective/preventive actions and effectiveness verification, and product risk assessments were not updated following labeling changes for the AmniSure ROM Test.

## Related Documents

- [483 - 2018-02-21](https://www.globalkeysolutions.net/records/483/qiagen-sciences-llc/215a9ad8-b17b-4aa2-9efd-222ae52eaa1d)

## Related Officers

- [Jude C. Dike](https://www.globalkeysolutions.net/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.globalkeysolutions.net/companies/qiagen-sciences-llc/501f56d6-2a3c-4109-9ff2-ec1ac76e696d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e