‘Objectionable Conditions’ at Florida Doctor Site
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 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.