The warning letter released Tuesday follows a Form 483 from last year and is related to an FDA inspection from Sept. and Oct. of 2012 in which Frazer was found to have not adhered “to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.”
Specifically, the FDA said Frazer failed to follow protocols that said “that you dispense a handheld electronic device (LogPad) to subjects” at a visit prior to surgery, and that “the subjects record their pain assessments in the LogPad during the study.” Frazer did not dispense a LogPad to one subject “because the subject was sedated and on a ventilator,” while five pain assessments for another subject “were entered into the LogPad by the study coordinator, rather than by the subject.”
“Although you explained how the violation occurred, you failed to provide a corrective action plan to prevent recurrence of similar violations in the future,” the FDA said.
The agency added that based on Frazer’s response to the Form 483, “we have concerns that your study coordinator may have inappropriately entered data into the LogPad for other subjects, as well.
“We request that you inform us, in writing, of the extent to which pain-assessment data were not obtained directly from the subjects; the extent to which anyone other than the subjects entered pain-assessment data into LogPads; and how you intend to prevent the recurrence of similar violations in the future.”
The FDA also said one patient did not meet the study protocol’s inclusion criteria.
In addition, the protocol prohibited the use of pain medications Percocet and Oxycontin (oxycodone hydrochloride), although one patient received Percocet and another received Oxycontin.
“Your failure to maintain adequate and accurate case histories by failing to maintain adequate and accurate pain assessments compromised the validity and integrity of data captured at your site,” the agency said.
Frazer did not respond to a request for comment by press time.