FDA EIR - Pfizer Inc. - August 23, 2012

An FDA Good Laboratory Practice (GLP) surveillance inspection was conducted at Pfizer Inc.'s Groton Laboratories from August 20 to August 23, 2012. The inspection, requested by the Center for Veterinary Medicine (CVM), focused on GLP activities supporting New Animal Drug Application (NADA) 141-322, with particular attention to multisite operations oversight. During this inspection, the FDA found no new deficiencies, and consequently, no Form FDA 483 was issued. Review of various documents, including organizational charts, standard operating procedures (SOPs), training records, and source data, revealed no remarkable observations. Notably, the previous GLP inspection in October 2010 had resulted in two findings: the study director's failure to transfer all raw data to archives and the Quality Assurance Unit's inadequate review of the final study report. These prior deficiencies were confirmed to have been adequately corrected by the time of the current inspection. The regulatory framework for this inspection was the Good Laboratory Practice regulations. Given the absence of new findings and the successful remediation of past issues, the FDA recommended a "No Action Indicated" (NAI) classification for the facility. The report has been referred to the Center for final review and classification, signifying the company's compliance during this period.