FDA EIR - Faro Ted Owiesy - June 27, 2018

The FDA conducted a compliance inspection of Sponsor-Investigator Dr. Faro Ted Owiesy at his Corona, CA facility from June 22 to June 27, 2018. This "for cause" inspection, prompted by concerns regarding an ongoing clinical trial while its Investigational New Drug (IND) application was on hold, assessed adherence to Good Clinical Practice regulations (specifically 21 CFR 312.42 and 21 CFR 312.40/312.20(b)). The inspection identified two main violations. First, Dr. Owiesy continued to consent, enroll, and administer investigational products to five subjects, and recruited five more, after being notified on August 10, 2017, that the study was under a full clinical hold. He also continued advertising and recruitment. Second, the clinical investigation began before the IND was in effect, with four subjects enrolled and treated between July 21 and August 17, 2017, without observing the mandatory 30-day waiting period following the IND application submission on July 10, 2017. Furthermore, a previous pilot study (2007-2013) involving the drug combination also proceeded without an IND. At the closeout, Dr. Owiesy received an FDA-483 detailing these observations. Required actions include immediately halting all recruitment, enrollment, and investigational product administration, and ceasing all study-related advertising until the clinical hold is removed. He must also revise the study protocol to include drug mixing procedures, a monitoring plan, deviation reporting, clear visit schedules, and standardized administration techniques. Additionally, proper informed consent procedures, documentation, and record-keeping for drug shipments and destruction must be established.