# FDA 483 - Kenia Castro, M.D. - January 07, 2022

Source: https://www.globalkeysolutions.net/records/483/kenia-castro-md/d45569f4-7d4d-470e-bd61-19c3b1227ca1

> FDA 483 for Kenia Castro, M.D. on January 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kenia Castro, M.D.
- Inspection Date: 2022-01-07
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Reliable Clinical Research, LLC in Hialeah, FL, was cited for deficiencies in conducting a clinical investigation. The firm randomized subjects who did not meet inclusion/exclusion criteria, violating the investigational plan. Additionally, the firm failed to promptly report two Serious Adverse Events (SAEs) to the sponsor as required by the study protocol.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/sheri-l-stephenson/dd4f3755-bb3b-4a14-a08f-8d59fbb0b6fa)

Company: https://www.globalkeysolutions.net/companies/kenia-castro-md/29ca1bd8-302c-4981-8c7e-5564c2317abf

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