# FDA 483 - Sun Dental Laboratories, LLC - September 20, 2023

Source: https://www.keypedia.com/records/483/sun-dental-laboratories-llc/59ce16ab-ae92-489e-ba40-52ecdaef9e03

> FDA 483 for Sun Dental Laboratories, LLC on September 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Dental Laboratories, LLC
- Inspection Date: 2023-09-20
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of Sun Dental Laboratories, LLC in Saint Petersburg, FL, revealed significant deficiencies in their quality system. The firm lacked written Medical Device Reporting procedures, failed to establish quality agreements with suppliers for their SunClear Aligners, and did not adequately examine labeling for required Unique Device Identifier (UDI) information. These observations indicate a need for improved quality control and regulatory compliance.

## Related Documents

- [483 - 2023-09-20](https://www.keypedia.com/records/483/sun-dental-laboratories-llc/20cbe95e-c1f3-4d16-af88-c481476d391d)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)

Company: https://www.keypedia.com/companies/sun-dental-laboratories-llc/8636b656-af45-4399-83f7-b85306cd84d4

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