FDA EIR - Weiner, Gilbert R. - April 30, 2015

An FDA inspection was conducted at the clinical investigator site of Dr. Gilbert R. Weiner and the associated Contract Research Organization (b)(4) from April 20 to April 30, 2015. This high-priority inspection was a pre-approval and follow-up review focused on compliance with Good Clinical Practice for investigational pharmaceutical trials, particularly Protocol CV181169.The inspection identified two main objectionable conditions. Firstly, there was a failure to prepare and maintain adequate case histories. This included a lack of documentation for when concomitant medication information was obtained and entered for all randomized subjects, and insufficient records at screening to confirm medication reviews as required by the protocol. Additionally, source documentation for (b)(4) analysis lacked kit lot numbers, expiration dates, and contemporaneous recording of results for all randomized subjects.Secondly, the investigation was not conducted in accordance with the signed statement of investigator and the investigational plan. A specific instance cited was a subject undergoing more (b)(4) procedures than permitted by the IRB-approved protocol. These issues represent deviations from regulatory requirements under 21 CFR 312.62(b) and 312.60.At the inspection's conclusion, a Form FDA 483 was issued, detailing these observations. Management acknowledged the findings and committed to providing a written response within 15 business days. The FDA strongly encouraged voluntary corrective actions to address the serious conditions and avoid potential legal sanctions.