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483
•Jeffrey Lancet, M.D.•August 24, 2016

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

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Record Details

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.

Company
Jeffrey Lancet, M.D.
Inspection Date
August 24, 2016
Product Type
Drugs
Office
Office of Medical Device and Radiological Health Division II
Person
  • Gene R. Gunn (investigator)
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ID · 5acaa67e-f768-4b13-bd49-4fa48cf4d091

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