FDA EIR - Pfizer Inc. - November 02, 2018

An FDA Bioresearch Monitoring inspection of Pfizer, Inc., located at 445 Eastern Point Rd, Groton, CT, was conducted from October 29 to November 2, 2018. This pre-announced sponsor inspection was initiated under an assignment memorandum from the FDA's Office of Scientific Investigations, Center for Drug Evaluation and Research (CDER), with guidance from CP7348.810 (Sponsors, Contract Research Organizations and Monitors). The inspection focused on Biologics License Application (BLA) #761103 and specifically covered clinical trial B3281006. The primary finding during the inspection was Pfizer's failure to accurately translate certain sections of the study protocol for clinical trial B3281006 into Greek and Portuguese languages. Despite this observation, the FDA did not issue a Form FDA-483, which typically details inspectional observations requiring a formal response. Instead, a general discussion was held with company management regarding this translation issue. The overall conclusion of the inspection was "No Action Indicated" (NAI), signifying that no formal regulatory action was required by the FDA at that time. This suggests that while an issue was identified, it was addressed through direct discussion rather than formal enforcement.