# FDA 483 - David F. Jativa, M.D. - April 25, 2022

Source: https://www.keypedia.com/records/483/david-f-jativa-md/50fb66a5-49d8-4c0d-9ecb-ab4eed4e8020

> FDA 483 for David F. Jativa, M.D. on April 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: David F. Jativa, M.D.
- Inspection Date: 2022-04-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of David F. Jativa, M.D. in Doral, FL, revealed that the clinical investigator failed to conduct a clinical study in accordance with the investigational plan. Specifically, the firm did not properly report, repeat, timely assess, or follow up on clinically significant safety laboratory assessments and adverse events for study subjects. These deficiencies indicate a significant lack of adherence to protocol requirements for subject safety and data integrity.

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Company: https://www.keypedia.com/companies/david-f-jativa-md/0fb6f32f-7dd1-42f7-b68d-8ad4cced8b00

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