FDA 483 - Jeffrey Lancet, M.D. - August 24, 2016

This FDA Form 483 was issued to Jeffrey Lancet, M.D. in Tampa, FL, following an inspection of their clinical investigator site. The inspection revealed significant repeat observations concerning failures to adhere to investigational plans and protocols, including missing subject safety data and unauthorized personnel consenting subjects, as well as issues with maintaining accurate case histories and data integrity.