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

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.