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

An FDA inspection conducted at the clinical research site of Keith A. Aqua, M.D., in Boynton Beach, FL, from February 3 to March 17, 2014, identified significant deficiencies in the conduct of two clinical trials. The inspection, performed under the Bioresearch Monitoring Compliance Program (CP 7348.811), revealed widespread non-compliance with investigational plans. Main violations included the failure of study subjects to self-record crucial pain assessment data as required by protocol, and the misclassification of subjects as "completers" despite not receiving the study device for the minimum required duration. Further issues encompassed inconsistencies in assessment timing, inadequate follow-up for subjects experiencing low oxygen saturation while on study drug, and incomplete end-of-study laboratory tests. The site also failed to record and return suspected device technical failures, ensure proper subject training, and accurately document protocol deviations. Eligibility sign-offs occurred prematurely, and significant discrepancies were found between various study records. At the conclusion, an FDA-483, Inspectional Observations, was issued to Dr. Aqua, who acknowledged responsibility and committed to submitting a written response with initiated corrective actions. The Agency outlined potential sanctions including warning letters or data exclusion for continued non-compliance.