# FDA 483 - ONTEL PRODUCTS CORPORATION - May 29, 2025

Source: https://www.globalkeysolutions.net/records/483/ontel-products-corporation/b632575c-31a6-4526-8301-89cb0c124d42

> FDA 483 for ONTEL PRODUCTS CORPORATION on May 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ONTEL PRODUCTS CORPORATION
- Inspection Date: 2025-05-29
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of ONTEL PRODUCTS CORPORATION, a specification developer in Fairfield, NJ, revealed significant deficiencies in their quality system. The firm failed to establish procedures for purchasing controls and supplier evaluation. Additionally, the company did not implement Unique Device Identifiers (UDI) on medical device labels and neglected to submit required device information to the Global Unique Device Identification Database (GUDID).

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ontel-products-corporation/11f04876-6585-4032-85b1-a87dd0c43450

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