UVLrx Therapeutics IncApril 4, 2017

FDA 483 - UVLrx Therapeutics Inc - April 04, 2017

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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.

Company: UVLrx Therapeutics Inc
Inspection Date: April 4, 2017
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Courtney N. Long (investigator)

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ID · d9aa3f52-ca4a-4a92-a1b0-6a00d7139708