Pfizer Inc. – FDA EIR, Jun 21, 2018

An FDA inspection was conducted at Pfizer, Inc.'s Groton, CT facility from June 11 to June 21, 2018. This high-priority inspection, requested by the Office of Scientific Investigations (OSI) within the FDA’s Center for Drug Evaluation and Research (CDER), focused on Pfizer’s responsibilities as a sponsor under the Bioresearch Monitoring (BIMO) program. The inspection specifically reviewed the investigational drug glasdegib (PF-04449913) and its associated study protocol B1371003. The inspection revealed two primary issues, for which an FDA Form 483 was issued. Firstly, Pfizer failed to adequately monitor the study and ensure its conduct adhered to the established protocol and investigational plan. This mirrors an observation from a previous BIMO inspection where no corrective action was taken by the firm. Secondly, the transfer of obligations to a contract research organization was not documented in writing. The inspection was carried out in accordance with regulatory guidance for Sponsors, Contract Research Organizations, and Monitors (CP 7348.810). The outcome of the inspection was classified as Voluntary Action Indicated (VAI), meaning the FDA identified objectionable conditions that the company is expected to address through voluntary corrective measures, without immediate regulatory enforcement action from the agency.