FDA Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator this week. Dr. Giron was warned for failing to follow the investigational plan (21 CFR 312.60), specifically:

  • Failing to collect protocol required Day 1 stool samples and provide them to the Central lab. FDA notes that the PI indicated that he believed samples were shipped as well as analyzed locally.
  • Failing to provide protocol required blood samples (pK, anti-drug antibodies) to the central lab. FDA notes that the PI observed samples being collected and stated that he believed they were shipped to the central lab. 
  • One subject was overdosed for close to a month by taking two extra tablets per day. FDA states "Your failure to ensure that subjects received the correct doses of investigational drug raises significant concerns about the reliability of the data from your site."