FDA WARNING_LETTER - Weiner, Gilbert R. - November 25, 2013

The FDA issued a Warning Letter to Gilbert A. Weiner, D.O., following an inspection from September 23 to November 25, 2013, regarding his conduct as a clinical investigator for Protocol (b)(4) of the investigational drug (b)(4). The inspection, part of FDA's Bioresearch Monitoring Program, identified significant violations of FDA regulations.

Dr. Weiner failed to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60]. Specifically, hypersensitivity assessment forms were not completed for 55 of 129 randomized subjects on Days 1 and 2, and for the day following dosing days (Days 2, 9, 37, 79). Additionally, subjects excluded by the protocol, such as family members of study staff (Subject 037, cousin of staff; Subject 004, son of staff), were enrolled.

He also failed to maintain adequate and accurate case histories [21 CFR 312.62(b)]. Signs and symptoms of hypersensitivity (e.g., tachycardia, nausea) reported on adverse event forms were not recorded on corresponding hypersensitivity assessment forms for subjects 032, 057, and 227. Hypersensitivity assessment forms were missing for multiple subjects across various dosing periods. Furthermore, some hypersensitivity assessment forms were signed and dated by Dr