FDA 483 - Carlos Lastra MD - January 13, 2020

Carlos Lastra MD, a clinical investigator in New Brunswick, NJ, was cited for significant deficiencies in informed consent procedures and adherence to investigational protocols. The firm failed to provide informed consent forms in a language understandable to subjects' representatives and did not ensure subjects completed required follow-up visits or telephone contacts according to study plans. These issues indicate serious concerns regarding patient safety and data integrity in clinical trials.