# FDA 483 - Access Dental Lab, LLC - June 28, 2021

Source: https://www.globalkeysolutions.net/records/483/access-dental-lab-llc/3a65f092-3a8a-47fb-800d-1130e3c11a3e

> FDA 483 for Access Dental Lab, LLC on June 28, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Access Dental Lab, LLC
- Inspection Date: 2021-06-28
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Access Dental Lab, LLC, a manufacturer of SmileDirectClub Clear Aligners, was inspected in Antioch, TN, revealing significant deficiencies across multiple quality system areas. The firm failed to adequately manage medical device reports and customer complaints, conduct proper design validation for impression kits, and perform complete risk analyses. Additionally, issues were noted with acceptance activities and the validation of software used in the quality system, indicating systemic problems in ensuring product quality and patient safety.

## Related Officers

- [Joseph J Stanek](https://www.globalkeysolutions.net/people/joseph-j-stanek/dcbd6694-95f1-4b1c-9af6-f33be403bb6f)
- [Mary A. Millner](https://www.globalkeysolutions.net/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.globalkeysolutions.net/companies/access-dental-lab-llc/defc91ed-3129-46d2-adff-01d568061553

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea