ONTEL PRODUCTS CORPORATIONMay 29, 2025

FDA 483 - ONTEL PRODUCTS CORPORATION - May 29, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore ONTEL PRODUCTS CORPORATION

Record Details

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).

Company: ONTEL PRODUCTS CORPORATION
Inspection Date: May 29, 2025
Product Type: Device
Office: New Jersey District Office
Person: Jonathan Ho

Open in Dashboard

ID · b632575c-31a6-4526-8301-89cb0c124d42