# FDA 483 - Surgical Direct, Inc. - March 24, 2026

Source: https://www.keypedia.com/records/483/surgical-direct-inc/d8b2997a-471a-4b4d-9c2f-318ed08adb56

> FDA 483 for Surgical Direct, Inc. on March 24, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Surgical Direct, Inc.
- Inspection Date: 2026-03-24
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of Surgical Direct, Inc., a medical device manufacturer in Orange City, FL, revealed significant deficiencies in their quality management system. The firm failed to adequately document risk management processes, maintain complete complaint and servicing records, conduct management reviews, and validate QMS software. These observations indicate a systemic lack of adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [Brandon P. Thompson](https://www.keypedia.com/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)

Company: https://www.keypedia.com/companies/surgical-direct-inc/98bfeb4a-fc50-4644-9509-c811b333b485

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9