FDA 483 - Scott H. Schecter, O.D. - February 06, 2023

Pinnacle Research Institute in Fort Lauderdale, FL, received a Form 483 with two observations following an FDA inspection. The firm failed to conduct an investigation in accordance with its investigational plan by enrolling subjects who did not meet the specified inclusion or exclusion criteria. Additionally, the firm was cited for not preparing or maintaining accurate case histories, specifically regarding the transcription of endpoint data for study subjects.