483
PhotonX Holdings Inc.PhotonX Holdings Inc. – FDA 483, Apr 4, 2017
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
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