FDA 483 - Uramix Inc - May 20, 2025

Uramix Inc, a manufacturer of class 2 sterile medical devices in Lansdowne, PA, was cited for significant deficiencies in its quality system. The inspection revealed a lack of established procedures for critical areas such as management controls, design controls, corrective and preventative actions, and customer complaint management. Additionally, the firm failed to develop and implement written procedures for Medical Device Reporting (MDR).