FDA EIR - Gregory J. Tracey, M.D. - April 15, 2015

An FDA inspection was conducted at Gregory J. Tracey, M.D., a Principal Investigator operating at Frontage Clinical, from March 25 to April 15, 2015. This was a for-cause Clinical Investigator Inspection under the FDA's Bioresearch Monitoring Compliance Program, focused on adherence to Good Clinical Practice for investigational drug studies. The primary violation cited in the FDA Form 483 was Dr. Tracey's failure to conduct a study according to the approved protocol. Specifically, a female subject was improperly enrolled and administered investigational product despite meeting multiple exclusion criteria due to pregnancy. The subject displayed consistently elevated serum human chorionic gonadotropin (HCG) levels across screening, re-screening, admission, and a follow-up visit. The protocol explicitly excluded pregnant or lactating females and those with positive serum pregnancy tests. This serious deviation resulted in the pregnant subject receiving the investigational product and subsequently experiencing a miscarriage. Upon conclusion of the inspection, Dr. Tracey received the FDA Form 483. He committed to providing a written response to the FDA within 15 days, detailing corrective and preventive actions. The FDA will review this response to determine any further regulatory follow-up actions required.