FDA 483 - Keith A. Aqua, M.D. - March 17, 2014

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.