483
Pablo H. Vivas, M.D.FDA 483 - Pablo H. Vivas, M.D. - August 22, 2019
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Record Details
Pablo H. Vivas, M.D., Clinical Investigator, was cited for significant deficiencies in the conduct of clinical investigations. The inspection revealed failures in promptly reporting serious adverse events, adherence to investigational plans and protocols, and maintaining accurate and adequate case histories. Additionally, investigational drug disposition records were found to be inadequate.
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ID · d5e0ca9f-f14e-4031-821d-84ff7a1b073d