# FDA 483 - Retrofix Screws LLC - July 01, 2022

Source: https://www.keypedia.com/records/483/retrofix-screws-llc/4bc6c125-462d-4d2a-8d29-34bffbe8a5b0

> FDA 483 for Retrofix Screws LLC on July 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Retrofix Screws LLC
- Inspection Date: 2022-07-01
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Retrofix Screws LLC in Salisbury, NC, revealed significant deficiencies in their quality system for orthopedic screws. The firm lacked adequate procedures and records for design validation, design plans, design output, process validation, nonconforming product control, and incoming product acceptance. These issues indicate a systemic failure to establish and follow essential quality system requirements for medical device manufacturing.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/retrofix-screws-llc/23827d92-03c7-4002-820e-fdfc123686fe

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7