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

Source: https://www.keypedia.com/records/483/scott-h-schecter-od/4faae4e9-a46c-4631-a581-b840bb62589c

> FDA 483 for Scott H. Schecter, O.D. on February 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scott H. Schecter, O.D.
- Inspection Date: 2023-02-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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Company: https://www.keypedia.com/companies/scott-h-schecter-od/03b3a06f-a8be-4a92-a931-dc18a1fea713

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6