# FDA 483 - Gilberto M. Cruz, M.D. - April 24, 2024

Source: https://www.keypedia.com/records/483/gilberto-m-cruz-md/cc33383b-4a71-4a5e-8239-d4e3603ce55a

> FDA 483 for Gilberto M. Cruz, M.D. on April 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gilberto M. Cruz, M.D.
- Inspection Date: 2024-04-24
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Reliable Clinical Research Llc in Hialeah, FL, a clinical investigator, received a Form FDA 483 with two observations. The firm failed to conduct an investigation in accordance with the investigational plan, specifically by enrolling a subject who did not meet inclusion criteria. Additionally, the firm did not prepare or maintain accurate case histories, showing discrepancies in recorded assessment times and electronic source data.

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Company: https://www.keypedia.com/companies/gilberto-m-cruz-md/e74660cb-672b-401b-8ed5-da8d7b49ee6c

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