FDA EIR - John Panuto, M.D. - December 06, 2017

An FDA inspection of John Panuto, M.D., and associated Clinical Research Solutions, located in Middleburg Heights, OH, was conducted from October 25 to December 6, 2017. This high-priority, for-cause inspection resulted from a complaint regarding Good Clinical Practice concerns and lack of principal investigator oversight in clinical trials. The inspection, carried out under CP 7348.811 Bioresearch Monitoring guidelines, revealed significant issues across multiple studies. Key violations, documented in an FDA Form 483, included a failure to conduct investigations according to the signed investigational plan, exemplified by enrolling an ineligible subject whose spirometry results were deemed unacceptable (21 CFR 312.60). Furthermore, investigational drug disposition records were found to be inadequate, with instances of drug kits recorded as dispensed but physically present on shelves, indicating poor accountability (21 CFR 312.62(a)). There was also a failure to maintain adequate case histories, with significant spirometry data missing from patient records (21 CFR 312.62(b)). Additional concerns raised during discussions included improper handling of investigational products, insufficient verified medical records to confirm subject eligibility for studies, discrepancies in subject consent form signatures, and delays in documenting adverse events. Dr. Panuto and Clinical Research Solutions management acknowledged these findings. In response, they committed to implementing new policies, such as two-person verification for investigational product dispensing and returns, and ensuring all data is accurately recorded before sign-off.