# FDA 483 - Pablo H. Vivas, M.D. - August 22, 2019

Source: https://www.keypedia.com/records/483/pablo-h-vivas-md/d5e0ca9f-f14e-4031-821d-84ff7a1b073d

> FDA 483 for Pablo H. Vivas, M.D. on August 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pablo H. Vivas, M.D.
- Inspection Date: 2019-08-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pablo H. Vivas, M.D., Clinical Investigator, was cited for significant deficiencies in the conduct of clinical investigations. The inspection revealed failures in promptly reporting serious adverse events, adherence to investigational plans and protocols, and maintaining accurate and adequate case histories. Additionally, investigational drug disposition records were found to be inadequate.

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-cooper/4813e60d-c8da-4df2-bc48-ecfb06a55cf8)

Company: https://www.keypedia.com/companies/pablo-h-vivas-md/807cac0c-b177-40a4-8a85-17acbddb3c97

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