# FDA 483 - Custom Smiles Sleep Department - March 18, 2022

Source: https://www.keypedia.com/records/483/custom-smiles-sleep-department/4ba3aa35-e645-4ccb-903c-5757295b4b9a

> FDA 483 for Custom Smiles Sleep Department on March 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Custom Smiles Sleep Department
- Inspection Date: 2022-03-18
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Custom Smiles Inc. in Kannapolis, NC, a contract manufacturer of medical devices, received a Form FDA 483 with 13 observations following an inspection from March 14-18, 2022. The inspection revealed significant deficiencies across its quality system, including a lack of documented process validation, inadequate complaint handling, issues with device history records and labeling, and a complete absence of quality audits, management reviews, and established quality policies. These findings indicate a severely underdeveloped and non-compliant quality management system.

## Related Officers

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Company: https://www.keypedia.com/companies/custom-smiles-sleep-department/9eca67be-749c-4bc4-b0c6-c527fab318e0

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7