Pfizer Inc. – FDA EIR, Apr 30, 2012

An FDA inspection of Pfizer Inc. in Groton, CT, was conducted from April 24 to April 30, 2012. This high-priority inspection was a pre-approval assessment for New Drug Application (NDA) 203341, concerning the drug bosutinib (SKI-606). The primary objective was to evaluate compliance with Good Clinical Practice (GCP) regulations, specifically focusing on the post-acquisition transfer of clinical study 3160A4-200-WW from a legacy company to Pfizer. The inspection concentrated on the processes for transferring data management, monitoring responsibilities, and safety information. A key finding noted that the data transfer for the bosutinib study took place in October 2011, which was subsequent to the March 28, 2011, database snapshot date. Similarly, the safety database transfer became operational in November 2011. Despite these observations regarding the timeline of data transfers, the FDA concluded the inspection with a "No Action Indicated" (NAI) classification. Crucially, no Form FDA 483, indicating significant inspectional observations or violations, was issued to Pfizer Inc. Consequently, no specific regulatory actions or corrective procedures were required from the firm as a direct result of this inspection. The report was referred to the Center for Drug Evaluation and Research (CDER) for final classification, which affirmed the NAI status.