FDA WARNING_LETTER - UVLRX Therapeutics Inc - April 04, 2017

This Warning Letter addresses objectionable conditions observed during an FDA inspection of UVLrx Therapeutics, Inc. from March 27 to April 4, 2017, concerning the clinical study "UVL_0001 A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly into a Peripheral Intravascular Catheter: A Safety and Feasibility Study." The UVLRX Station is classified as a device.

The inspection revealed serious violations of 21 CFR Part 812 - Investigational Device Exemptions. Key violations include: 1. **Failure to obtain Institutional Review Board (IRB) approval:** The firm failed to obtain IRB approval for multiple studies, increased enrollment (e.g., 3,063 subjects enrolled vs. 1,000 approved), and used unapproved clinical investigators. 2. **Failure to monitor investigations:** The firm did not monitor studies or maintain documentation, leading to investigational products being shipped to unapproved/unqualified investigators and exceeding approved subject enrollment. 3. **Failure to maintain required records:** The firm failed to maintain records of adverse device effects and complete disposition records for devices. 4. **Failure to label the device in accordance with 812.5:** Devices were shipped without proper investigational device caution statements. 5. **Failure to obtain informed consent:** No documentation demonstrated that investigators obtained informed consent from subjects as required by