FDA 483 - Nayvis Iglesias, MD - July 29, 2021

Nayvis Iglesias, a Clinical Investigator in Coral Gables, FL, was cited for significant deficiencies during an FDA inspection. The inspection revealed that the investigator enrolled and treated subjects who did not meet the study's inclusion/exclusion criteria without proper waivers. Additionally, the firm failed to maintain accurate case histories due to transcription errors between source documents and electronic case report forms.