483
UVLrx Therapeutics IncFDA 483 - UVLrx Therapeutics Inc - April 04, 2017
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Record Details
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.
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ID · d9aa3f52-ca4a-4a92-a1b0-6a00d7139708