The FDA warned investigational medical device sponsor UVLrx Therapeutics for eight violations an FDA investigator observed during an inspection of its Florida facility from March 27 through April 4.
UVLrx failed to obtain required approvals from its Institutional Review Board, comply with monitoring requirements, maintain records of adverse device effects, or apply proper labeling to its investigational products, the investigator found.
The sponsor enrolled thousands more human subjects in a study protocol than the number approved by the IRB — 3,063 vs. 1,000 subjects — and shipped investigational devices to at least ten unapproved clinical investigators who treated subjects. These are serious violations, the FDA said, because “there is no assurance that the rights and welfare of subjects were adequately protected” without the approvals.
