# FDA WARNING_LETTER - UVLRX Therapeutics Inc - April 04, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/uvlrx-therapeutics-inc/419d07d2-a94d-4fe9-a3ec-b54838562d95

> FDA WARNING_LETTER for UVLRX Therapeutics Inc on April 04, 2017. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: UVLRX Therapeutics Inc
- Inspection Date: 2017-04-04
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/robin-w-newman/b6370aff-a764-49c2-88db-a0f407f46f7f)

Company: https://www.globalkeysolutions.net/companies/uvlrx-therapeutics-inc/c4e0e47e-5c74-444c-9616-733c47c3bb97

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7