# FDA 483 - UVLrx Therapeutics Inc - April 04, 2017

Source: https://www.globalkeysolutions.net/records/483/uvlrx-therapeutics-inc/d9aa3f52-ca4a-4a92-a1b0-6a00d7139708

> FDA 483 for UVLrx Therapeutics Inc on April 04, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UVLrx Therapeutics Inc
- Inspection Date: 2017-04-04
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: UVLrx Therapeutics Inc. in Oldsmar, FL, was inspected regarding its investigational device studies. The inspection revealed significant deficiencies in IRB oversight, investigator qualifications, device control, adverse event reporting, and labeling. These issues indicate a lack of proper controls over clinical investigations and investigational device management.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)

Company: https://www.globalkeysolutions.net/companies/uvlrx-therapeutics-inc/6fc1d2a0-85c1-4383-b4eb-eef4f624c08b

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6