FDA EIR - Dimitri Sirakoff, D.O. - February 06, 2013

The FDA conducted an unannounced, for-cause inspection of Dimitri Sirakoff, D.O., operating as Trinity Clinical Trials in Santa Ana, CA, from January 9, 2013, to February 6, 2013. This inspection, performed under Compliance Program 7348.811 for Clinical Investigators, reviewed two drug study protocols regulated by sections 505(i) of the Federal Food, Drug, and Cosmetic Act.

During the inspection, several objectionable conditions were identified, leading to the issuance of a 3-item FDA-483. The main violations included the administration of study drugs to subjects by Clinical Research Coordinators without the direct supervision of Dr. Sirakoff or a responsible sub-investigator, contrary to the investigational plan and the investigator's signed statement. Furthermore, there was a failure to prepare or maintain accurate case histories, with progress notes falsely indicating Principal Investigator administration and records showing drugs administered before preparation for some subjects. Other issues noted included a 'missing' regulatory binder for one protocol and abnormal lab values that were not reported as adverse events for another.

At the close-out, Dr. Sirakoff acknowledged the findings and committed to implementing voluntary corrections and providing a written response to the district within 15 days.