# FDA 483 - IZI Medical Products, LLC - September 12, 2025

Source: https://www.keypedia.com/records/483/izi-medical-products-llc/5941b3e8-e5fc-499b-9c57-1af3322614ff

> FDA 483 for IZI Medical Products, LLC on September 12, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IZI Medical Products, LLC
- Inspection Date: 2025-09-12
- Product Type: device
- Office Name: Baltimore District Office
- Summary: 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.

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/izi-medical-products-llc/d01625c7-68fd-4e16-b10b-2947d77bd6d0

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa