# FDA 483 - Turncare, Inc - December 11, 2024

Source: https://www.keypedia.com/records/483/turncare-inc/1c255d62-4160-47b3-9e51-ab15b3b60ec6

> FDA 483 for Turncare, Inc on December 11, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Turncare, Inc
- Inspection Date: 2024-12-11
- Product Type: device
- Office Name: New Jersey District Office
- Summary: During an inspection from November to December 2024, Turncare, Inc. of Pompton Plains, NJ, was cited for failing to report violations of the FD&C Act involving their Guardian System 2 Controllers, which might present a risk to health. Specifically, the firm did not report or justify not reporting software malfunctions that caused devices to fail in delivering intended therapy. This indicates a significant lapse in their adverse event reporting and recall procedures.

## Related Documents

- [483 - 2023-06-26](https://www.keypedia.com/records/483/turncare-inc/85ac333f-291e-45fc-bcb1-58a358e74b0d)

## Related Officers

- [Monica L. Gutierrez](https://www.keypedia.com/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)

Company: https://www.keypedia.com/companies/turncare-inc/1df2c7e7-aa75-466c-a9c3-eab33580cdc5

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248