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# ‘Objectionable Conditions’ at Florida Doctor Site
- URL: https://www.fdaweb.com/objectionable-conditions-at-florida-doctor-site/
- Published: 2023-10-04T12:00:00.000Z
- Updated: 2026-09-14T19:00:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155479

A 1/9-1/23 FDA Bioresearch Monitoring Program inspection at a clinical site maintained by Dr. **Luis Pena-Hernandez** in Atlantis, FL, found objectionable conditions in which Pena-Hernandez did not adhere to the applicable statutory requirements and regulations governing the conduct of clinical investigations and the protection of human subjects. A 9/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/luis-javier-pena-hernandez-md-fccp-668217-09202023?ref=fdaweb.com) says specific violations were:

- failing to ensure that the investigation was conducted according to the investigational plan; and
- failing to ensure that an institutional review board that complies with regulations was responsible for the initial and continuing review and approval of the proposed clinical study.

FDA says Pena-Hernandez’ responses to the inspection findings were inadequate. He was told to respond with a list of specific actions he has taken to prevent similar violations in the future.