FDA EIR - Pfizer Inc. - October 05, 2018

This FDA Establishment Inspection Report details a high-priority sponsor inspection of Pfizer, Inc., located in Groton, CT, conducted from October 2 to October 5, 2018. The inspection was initiated by the Center for Drug Evaluation and Research, focusing on Pfizer's sponsor responsibilities under Compliance Program 7348.810. The review specifically examined studies submitted under NDA 207103 S-0008, including Protocol A5481097 and Sub-study #19, which involved retrospective claims data and real-world analysis of metastatic breast cancer in males in the United States.

A previous inspection on June 21, 2018, resulted in an FDA-483 due to issues such as inadequate study monitoring, non-adherence to the investigational plan, and insufficient written documentation for transferring obligations to a contract research organization. That inspection was classified as Voluntary Action Indicated (VAI), implying corrective actions were required from Pfizer.

In contrast, the more recent October 2018 inspection, which included a thorough review of contracts, standard operating procedures, training records, and raw data, concluded with "No Action Indicated" (NAI). No new FDA-483 was issued, and no samples or refusals were encountered, indicating that Pfizer was found to be in satisfactory compliance during this particular inspection.