Pfizer Inc. – FDA EIR, Jun 6, 2012

An FDA inspection of Pfizer Inc. in Groton, CT, conducted from May 7, 2012, to June 6, 2012, served as a follow-up to a previous Warning Letter issued in April 2010. The inspection aimed to evaluate Pfizer's adherence to Good Clinical Practice (GCP) commitments. Based on the findings, a Form FDA 483, detailing inspectional observations, was issued. The primary violations identified were the firm's failure to consistently follow its procedure for assessing and acting upon reports of study deviations concerning adverse effects or safe use of study drugs. Additionally, Pfizer did not adhere to protocol requirements for selecting qualified raters for study-specific assessments, granting waivers to individuals who lacked the necessary education or experience. The regulatory framework for this inspection was a high-priority, for-cause follow-up, assigned by CDER's Office of Scientific Investigations. Pfizer submitted a written response to the observations on June 27, 2012. The required actions include a 'Voluntary Action Indicated' (VAI) classification, mandating Pfizer to confirm remaining Corrective and Preventive Actions (CAPA) commitments during a future PDUFA inspection. The case was referred to CDER for final classification.