FDA Sponsor-Investigator Warning Letter

FDA posted a warning letter this week to a Sponsor-Investigator.

Dr. Kang was warned for:

  • Failing to follow the investigation plan, specifically
    • Enrolling five subjects that did not meet protocol inclusion criteria (a 5 letter loss on a ETDRS visual test)
    • Enrolling a subject without a required test on Day 0. FDA did not accept that a test performed as standard of care three months prior to Day 0 was acceptable.
    • Failing to perform a require end of treatment visit as required for the protocol. FDA notes that the end of treatment visit was not done, although the patient continued to see Dr. Kang.
  • Failing to maintain adequate drug disposition records, as there were no documents indicating the disposition of 25 units of study drug.

The warning letter details Dr. Kang's responses to the Form 483 issued at the conclusion of the inspection, specifically:


  • "You indicated that you understand that stringent adherence to the inclusion and exclusion criteria should be used to assess eligibility, and that any amendment to the inclusion and exclusion criteria should first be approved by the Institutional Review Board (IRB). You also indicated that for all current and future studies, a “Secondary Reviewer Screening Process” will be implemented to review inclusion and exclusion criteria for each newly enrolled subject within at least a 24-hour screening period after informed consent has been obtained."
  • "You indicated that study staff has been retrained on the importance of monitoring for adverse events during the early termination assessments. Specifically, you indicated that study staff will receive one-on-one retraining in IRB regulations, reporting timelines, and other regulations, documentation of which you noted should be provided to the FDA in 30 days. "
  • "You indicated that study staff will be retrained on the importance of maintaining accurate and complete records of the investigational drug. You indicated that you have written a detailed plan for monitoring accurate and complete drug accountability records in a standard operating procedure (SOP), which you intended to provide to FDA within 30 days of the transmittal of your response to the Form FDA 483.  You also indicated that you planned to conduct a study closure visit to reconcile drug accountability, ensure destruction of expired supplies of the drug, and ensure completion and retention of all study records."

FDA notes repeatedly within the letter that the proposed corrective actions are inadequate, specifically "We are unable to undertake an informed evaluation of your written response because you did not provide a corrective action plan that, if properly carried out, would prevent this type of violation in the future. Specifically, you did not provide sufficient details about your plan for implementing additional measures and procedures, to address the inspection findings concerning your failure..."