# FDA 483 - Juan M. Ruiz-Unger, M.D. - September 22, 2021

Source: https://www.keypedia.com/records/483/juan-m-ruiz-unger-md/22d6218e-0737-4348-a3b8-515516887e33

> FDA 483 for Juan M. Ruiz-Unger, M.D. on September 22, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Juan M. Ruiz-Unger, M.D.
- Inspection Date: 2021-09-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA issued a Form 483 to Juan M. Ruiz-Unger, M.D., a clinical investigator in Palmetto Bay, FL, following an inspection that revealed significant deviations from the investigational plan. The firm failed to confirm subject eligibility criteria, conduct required safety screenings, and properly review or document laboratory reports for subjects enrolled in a clinical study. These deficiencies resulted in the randomization and treatment of subjects who did not meet the study's protocol requirements.

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Company: https://www.keypedia.com/companies/juan-m-ruiz-unger-md/aaae5f9a-b2bc-41cf-9ca5-6bb5976963de

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