FDA Sponsor-Investigator Warning Letter

FDA posted a warning letter this week to a Sponsor-Investigator. After an inspection that ranged over one month, Dr. Benson was warned for the failing to follow the investigational plan, specifically:

  • Dosing two subjects without platelet testing within the prior two weeks, contrary to protocol requirements
  • Enrolling one subject with renal insufficiency, contrary to protocol requirements
  • Failing to perform a total of seven laboratory tests across five subjects, including urinalysis, uric acid, magnesium and phosphorous