# FDA 483 - Rosa M. Suarez, M.D. - March 10, 2023

Source: https://www.keypedia.com/records/483/rosa-m-suarez-md/fb573f0b-dc87-4cef-8e6d-ce0a30688486

> FDA 483 for Rosa M. Suarez, M.D. on March 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rosa M. Suarez, M.D.
- Inspection Date: 2023-03-10
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Rosa M. Suarez, Clinical Investigator, received a Form 483 following an FDA inspection in Miami, FL, citing significant deviations in clinical trial conduct. Observations included failures to adhere to investigational plans, such as enrolling subjects who did not meet criteria, incorrect product randomization and administration, and inadequate case histories. Additionally, informed consent procedures were not properly followed, with some protocol-specific procedures performed before subjects signed consent forms.

## Related Officers

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

Company: https://www.keypedia.com/companies/rosa-m-suarez-md/62922b39-e983-49af-acd4-6c6790c7943b

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