# FDA 483 - Qiagen Sciences LLC - February 21, 2018

Source: https://www.globalkeysolutions.net/records/483/qiagen-sciences-llc/215a9ad8-b17b-4aa2-9efd-222ae52eaa1d

> FDA 483 for Qiagen Sciences LLC on February 21, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Qiagen Sciences LLC
- Inspection Date: 2018-02-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Qiagen Sciences LLC in Germantown, MD, was cited for two significant issues during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within the required timeframe for devices that may have caused or contributed to serious injury. Additionally, their complaint files were not adequately maintained, specifically regarding monthly complaint trending and subsequent investigations.

## Related Documents

- [483 - 2021-07-16](https://www.globalkeysolutions.net/records/483/qiagen-sciences-llc/c79300a6-193b-4258-9bdb-8ec24a4c743f)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/james-m-simpson/3c0113ae-d846-4e37-aafa-13d58c465fa3)

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