# FDA 483 - Five Star Orthodontic Laboratory & Supply, Inc. - March 17, 2025

Source: https://www.keypedia.com/records/483/five-star-orthodontic-laboratory-supply-inc/17f5a952-08b0-48ac-97e7-b4e059b08764

> FDA 483 for Five Star Orthodontic Laboratory & Supply, Inc. on March 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Five Star Orthodontic Laboratory & Supply, Inc.
- Inspection Date: 2025-03-17
- Product Type: device
- Office Name: Dallas District Office
- Summary: Five Star Orthodontic Laboratory & Supply, Inc. in Denton, TX, a manufacturer of orthodontic devices, was cited for multiple significant deficiencies in its quality system during an FDA inspection. The observations highlight systemic issues across corrective and preventive actions, device history records, complaint handling, recordkeeping, equipment maintenance, supplier management, and employee training. These findings indicate a broad lack of adherence to established procedures and regulatory requirements, posing a risk to product quality and patient safety.

## Related Officers

- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/five-star-orthodontic-laboratory-supply-inc/54a326e4-344f-46cb-bad2-f7917f54ddf1

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9