# FDA 483 - S. Jackson, Incorporated - February 07, 2025

Source: https://www.keypedia.com/records/483/s-jackson-incorporated/cfe454c4-ad9b-40a1-9802-9ea9f5217035

> FDA 483 for S. Jackson, Incorporated on February 07, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: S. Jackson, Incorporated
- Inspection Date: 2025-02-07
- Product Type: device
- Office Name: Baltimore District Office
- Summary: S. Jackson, Incorporated, a medical device manufacturer in Alexandria, VA, was cited for inadequate procedures to control nonconforming product. The firm failed to create nonconformance reports for issues with materials received from its contract manufacturer, including incorrect suture material, needles, and foreign objects. This indicates a significant lapse in quality control processes.

## Related Documents

- [483 - 2021-12-10](https://www.keypedia.com/records/483/s-jackson-incorporated/21022152-fe64-42ea-8c87-532694abb03b)

## Related Officers

- [Heath A. Gerber](https://www.keypedia.com/people/heath-a-gerber/3c47dcdd-875c-4f3c-8165-839354a53d8b)

Company: https://www.keypedia.com/companies/s-jackson-incorporated/d694eb90-15cf-444d-8686-556c7c597794

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa