IZI Medical Products, LLCSeptember 12, 2025

FDA 483 - IZI Medical Products, LLC - September 12, 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 IZI Medical Products, LLC

Record Details

IZI Medical Products, LLC, a medical device manufacturer in Owings Mills, MD, was cited for significant quality system deficiencies. The inspection revealed failures in timely Medical Device Reporting for serious malfunctions, inadequate complaint evaluation procedures, and widespread issues with document control. Additionally, the firm demonstrated poor record storage practices, leading to lost validation and training records.

Company: IZI Medical Products, LLC
Inspection Date: September 12, 2025
Product Type: Device
Office: Baltimore District Office
Person: Jude C. Dike

Open in Dashboard

ID · 5941b3e8-e5fc-499b-9c57-1af3322614ff