# FDA 483 - RESET TECHNOLOGY CORPORATION - December 20, 2024

Source: https://www.globalkeysolutions.net/records/483/reset-technology-corporation/b904154f-00fd-4f60-a335-fffecbc13c31

> FDA 483 for RESET TECHNOLOGY CORPORATION on December 20, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: RESET TECHNOLOGY CORPORATION
- Inspection Date: 2024-12-20
- Product Type: device
- Office Name: New Jersey District Office
- Summary: RESET TECHNOLOGY CORPORATION, a manufacturer of ResetSmile devices in Englewood Cliffs, NJ, was cited with 12 observations during an FDA inspection from October to December 2024. The inspection revealed significant deficiencies across its quality system, including a lack of documented procedures for process validation, design controls, nonconforming product, rework, environmental controls, complaint handling, CAPA, training, and software validation. Additionally, the firm failed to label devices with Unique Device Identifiers (UDI) and submit required information to the GUDID.

## Related Officers

- [Jonathan Ho](https://www.globalkeysolutions.net/people/jonathan-ho/434f1c30-b660-4bc9-bc31-017366282edd)

Company: https://www.globalkeysolutions.net/companies/reset-technology-corporation/e0e48a4c-5150-44b8-891f-362e33b944cc

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