# FDA 483 - DeGen Medical Inc. - August 29, 2019

Source: https://www.globalkeysolutions.net/records/483/degen-medical-inc/d93d154a-d566-411e-8744-a5a8f096f054

> FDA 483 for DeGen Medical Inc. on August 29, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DeGen Medical Inc.
- Inspection Date: 2019-08-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of DeGen Medical Inc. in Florence, SC, a specification developer, revealed significant deficiencies in their quality system. The firm failed to adequately investigate device complaints, specifically regarding a rod holder that broke during surgery. Additionally, procedures for controlling nonconforming products were not adequately established, as evidenced by uninvestigated incorrect screws and a lack of documented corrective and preventive actions.

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.globalkeysolutions.net/companies/degen-medical-inc/6093eda0-b69b-437f-bc3e-978d0f0eb18c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6