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.
In addition, the FDA investigator saw no documentation that the clinical investigators had completed training or documentation of any potential adverse device effects, which may have impacted the study’s subjects and collected data. And the sponsor’s failure to include the investigational device caution statement in its labeling before shipping the devices to study sites could lead to incorrect use and adverse event tracking, the warning letter said.
The FDA requested final copies of all of the new and revised SOPs, as well as documentation to show all research staff were adequately trained, and a plan for proper labeling of investigational products, among other corrective actions.