# FDA 483 - Contour Healer LLC - September 15, 2023

Source: https://www.globalkeysolutions.net/records/483/contour-healer-llc/772e9377-adea-41a1-be8d-a134818c9642

> FDA 483 for Contour Healer LLC on September 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Contour Healer LLC
- Inspection Date: 2023-09-15
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Contour Healer LLC in Virginia Beach, VA, a manufacturer of Contour Healer devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for acceptance activities, purchasing controls, and management review. These issues indicate a lack of robust quality management practices.

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/contour-healer-llc/ce33b9ee-7b7e-4822-a89f-4ea27fd77b79

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64