# FDA 483 - GPS DENTAL LAB, INC - November 05, 2024

Source: https://www.keypedia.com/records/483/gps-dental-lab-inc/c1ef1a77-d391-4e1a-9459-ad192e3080ea

> FDA 483 for GPS DENTAL LAB, INC on November 05, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GPS DENTAL LAB, INC
- Inspection Date: 2024-11-05
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of GPS DENTAL LAB, INC in Orlando, FL, revealed extensive deficiencies in their quality system for manufacturing class 2 medical devices. The firm lacked established procedures for critical areas including complaint handling, nonconforming product control, corrective and preventive actions, equipment calibration, and supplier evaluation. These widespread issues indicate a fundamental failure to ensure devices are produced in accordance with regulatory requirements.

## Related Officers

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

Company: https://www.keypedia.com/companies/gps-dental-lab-inc/beedde77-b3a9-4629-a735-379912e86bbc

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