FDA EIR - Pfizer, Inc. - April 19, 2023

Pfizer, Inc. underwent an FDA Establishment Inspection at its Groton, CT facility from April 11 to April 19, 2023. This was a mission-critical, high-priority PDUFA surveillance inspection for a sponsor of human clinical trials, conducted under Good Clinical Practice guidelines and Compliance Program 7348.810 for Sponsors and Contract Research Organizations. The inspection focused on a specific clinical study supporting a Biologics License Application (BLA) and an Investigational New Drug (IND). Key areas reviewed included ClinicalTrials.gov compliance, site training, safety monitoring, investigational product control, financial disclosures, and oversight of eight selected clinical sites. While the overall inspection concluded without the issuance of a Form FDA 483, indicating no objectionable conditions requiring immediate regulatory action, the report highlighted repeated instances of source data inaccuracies, CRF data entry discrepancies, and non-compliance with Pfizer procedures at a specific clinical site (site 1102). In response to these internal findings, Pfizer and its Contract Research Organization partners initiated an audit, increased monitoring, retrained the clinical investigator, and implemented a remediation plan for the affected site. No specific regulatory actions were mandated by the FDA at the conclusion of this inspection.