# FDA 483 - Enrique S. Hanabergh, MD - June 23, 2021

Source: https://www.keypedia.com/records/483/enrique-s-hanabergh-md/4f3336bb-9928-489d-86e4-1cb03fcef0af

> FDA 483 for Enrique S. Hanabergh, MD on June 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Enrique S. Hanabergh, MD
- Inspection Date: 2021-06-23
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Enrique S. Hanabergh, MD, a clinical investigator in Miami, FL, revealed significant deficiencies in the conduct of two investigational drug trials. Observations included a failure to properly supervise subjects by qualified medical personnel and a failure to maintain adequate and accurate case histories. These issues involved missing lab results, inconsistent subject contact documentation, and a serious lack of adherence to investigational plans and good clinical practice.

## Related Officers

- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.keypedia.com/companies/enrique-s-hanabergh-md/be07637a-8252-4a10-84bc-2f9cd80c06b2

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