483
Kathryn Lucas, M.D.FDA 483 - Kathryn Lucas, M.D. - August 27, 2018
Record Details
An FDA inspection of Kathryn Lucas, Clinical Investigator, in Morehead City, NC, revealed significant non-compliance with clinical investigational plans and record-keeping. Observations included failures to conduct investigations according to protocol, delayed reporting of serious adverse events, and inadequate maintenance of accurate case histories. These issues indicate a serious lack of adherence to regulatory requirements for clinical trials.
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ID · b0ab9ff9-a41e-4876-b378-1b96f68aa044