# FDA 483 - Medegen Medical Products, LLC - May 19, 2023

Source: https://www.keypedia.com/records/483/medegen-medical-products-llc/06c2e2ee-05a9-484c-a085-a08dada0475d

> FDA 483 for Medegen Medical Products, LLC on May 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medegen Medical Products, LLC
- Inspection Date: 2023-05-19
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Medegen Medical Products, LLC in Gallaway, TN, was inspected from May 15-19, 2023, and received a Form FDA 483 with five observations, many of which were repeated from previous inspections. The observations primarily concern inadequate procedures for quality system elements including corrective and preventive actions, acceptance activities, control of non-conforming product, device history records, and complaint handling. These issues indicate significant deficiencies in the firm's quality management system for medical device manufacturing.

## Related Documents

- [483 - 2019-10-10](https://www.keypedia.com/records/483/medegen-medical-products-llc/2dc3d185-fe11-4cd2-b093-a50b3a7f99ef)

## Related Officers

- [Javelle P. Spann](https://www.keypedia.com/people/javelle-p-spann/31a8f7a8-e442-4f5a-b33f-55bfe911e61b)
- [Ulysses D. Singleton](https://www.keypedia.com/people/ulysses-d-singleton/e62f9da3-2c82-4ad7-910d-2da18144c789)

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

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