# FDA 483 - Simpex Medical Inc - June 28, 2024

Source: https://www.globalkeysolutions.net/records/483/simpex-medical-inc/6cc5cdd4-3ac5-4edf-a238-0416e2871069

> FDA 483 for Simpex Medical Inc on June 28, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Simpex Medical Inc
- Inspection Date: 2024-06-28
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Simpex Medical Inc, a specification developer of K-wire and S-pin medical devices in Fort Mill, SC, revealed five significant quality system deficiencies, including two repeat observations. The firm lacked adequate procedures for design controls, process validation, sampling plans, device labeling, and equipment calibration, indicating a systemic failure to meet regulatory requirements for medical device manufacturing. These findings suggest a high level of non-compliance impacting device quality and safety.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/simpex-medical-inc/a140336e-293a-4625-a8df-c9aecf7ade2b

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