# FDA 483 - Medegen Medical Products, LLC - October 10, 2019

Source: https://www.globalkeysolutions.net/records/483/medegen-medical-products-llc/2dc3d185-fe11-4cd2-b093-a50b3a7f99ef

> FDA 483 for Medegen Medical Products, LLC on October 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medegen Medical Products, LLC
- Inspection Date: 2019-10-10
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Medegen Medical Products, LLC in Gallaway, TN, a medical device manufacturer, revealed significant deficiencies in their quality management system. Observations included inadequate process validation for sharps containers and specimen collection cups, ineffective corrective and preventive actions, and insufficient procedures for finished device acceptance. The firm also failed to adequately control non-conforming products and maintain complete device history records.

## Related Documents

- [483 - 2023-05-19](https://www.globalkeysolutions.net/records/483/medegen-medical-products-llc/06c2e2ee-05a9-484c-a085-a08dada0475d)

## Related Officers

- [Nicholas Z. Lu](https://www.globalkeysolutions.net/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.globalkeysolutions.net/companies/medegen-medical-products-llc/536c94a8-a16c-4a86-80c2-00a15ff58523

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea