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483
•Keith A. Aqua, M.D.•March 17, 2014

Keith A. Aqua, M.D. – FDA 483, Mar 17, 2014

Record Details

An FDA inspection of Keith A. Aqua, M.D., Clinical Investigator, in Boynton Beach, FL, revealed significant non-compliance with investigational plans and regulatory requirements for clinical trials IAP310 and IAP311. The firm failed to conduct studies according to protocol, report unanticipated problems to the IRB, and maintain accurate case histories. These deficiencies indicate a serious lack of oversight and adherence to clinical research standards.

Company
Keith A. Aqua, M.D.
Inspection date
March 17, 2014
Product type
drugs
Office
Office of Medical Device and Radiological Health Division II
Person
  • Colleen Aspinwall
View Company Profile

ID · 0233884d-e28d-4f89-bc99-9e2768d18174

Other documents for Keith A. Aqua, M.D.
  • EIR - 2014-03-17March 17, 2014

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