FDA WARNING_LETTER - Susan P. King-Harris, D.P.M. - May 09, 2019

This FDA Warning Letter, dated September 17, 2019, addresses Dr. King-Harris regarding objectionable conditions observed during an FDA inspection from April 29 to May 9, 2019, at their clinical site. The inspection, part of the Bioresearch Monitoring Program, reviewed Dr. King-Harris's conduct as sponsor-investigator of a clinical investigation involving the investigational drug (b)(4).

The primary violation identified was the failure to ensure the investigation was conducted according to the investigational plan, specifically regarding subject eligibility [21 CFR 312.60]. The protocol required subjects to have an intermetatarsal angle (IMA) between 10 and 15 degrees for bunion severity, excluding those with an IMA greater than 15 degrees. The inspection found that IMA measurements were not performed for all 14 subjects enrolled between June 2008 and December 2014, preventing full evaluation of eligibility.

Dr. King-Harris's May 22, 2019, response acknowledged inadequate screening, attributing it to a lack of experience. However, the FDA found the response insufficient as it did not specify personal corrective actions taken as a sponsor and clinical investigator, noting that most actions appeared to be from Beaumont Hospital. The FDA emphasized that enrolling ineligible subjects risks subject safety and welfare, and compromises data validity.

Dr. King-Harris must notify