FDA WARNING_LETTER - Sohail M. Khan, M.D. - July 14, 2017

On October 10, 2017, the FDA issued a Warning Letter to Sohail M. Khan, M.D., following a July 14, 2017, inspection of his clinical site. The inspection, part of the Bioresearch Monitoring Program, evaluated Dr. Khan's conduct of clinical investigations for Protocols CQVA149A2336 (Novartis) and two other protocols (b)(4).

The primary violation identified was the failure to retain records required under 21 CFR 312.62(c). Specifically, for Protocols CQVA149A2336 and (b)(4), Dr. Khan failed to retain records of drug disposition (dates, quantity, subject use) and adequate/accurate case histories, including signed informed consent forms, case report forms, and supporting data. These records were required because the New Drug Application for Protocol CQVA149A2336 was approved on October 29, 2015, and Protocol (b)(4) was discontinued at his site on October 14, 2015, meaning the two-year retention period had not elapsed for either.

During the inspection, Dr. Khan stated all study records for these protocols had been shredded or destroyed, and he possessed no paper or electronic records for any studies conducted. His July 25, 2017, response