# FDA 483 - Horizon Scientific - April 18, 2025

Source: https://www.globalkeysolutions.net/records/483/horizon-scientific/a543dc42-660e-4727-a09e-c0c49b1035fd

> FDA 483 for Horizon Scientific on April 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Horizon Scientific
- Inspection Date: 2025-04-18
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Horizon Scientific in Summerville, SC, revealed three significant observations related to their quality system. The firm failed to establish adequate procedures for servicing activities, lacked signed agreements with suppliers and contractors, and had insufficient document control procedures, including listing an incorrect user manual revision in device history records. These findings indicate deficiencies in maintaining a compliant quality management system.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/horizon-scientific/6cea5147-e370-47ae-8065-53af52aca9b3

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