Pfizer Inc. – FDA EIR, Jun 9, 2011

An FDA inspection was conducted at Pfizer Inc.'s Groton, CT facility from June 6 to June 9, 2011. This high-priority inspection, assigned by the Good Clinical Practice Branch II, Division of Scientific Investigations, reviewed clinical trials for protocols A8081001 and A8081005, primarily focusing on sponsor responsibilities under C.P. 7348.810. Significantly, no FDA Form 483 (Inspectional Observations) was issued during this inspection, indicating no significant violations were identified by the FDA. This contrasts with previous inspections, including one in 2009 at Pfizer's New London facility, which resulted in an Official Action Indicated classification and a Warning Letter for issues such as unqualified investigators and monitors, failure to adhere to investigational plans, and inadequate adverse event reporting. During the current inspection, Pfizer demonstrated improved oversight. While the company internally identified instances of investigator non-compliance, such as incorrect test article administration or missing informed consent documentation at specific sites, these issues were reportedly handled adequately and promptly rectified by Pfizer, ensuring compliance. The inspection found no evidence of underreporting adverse events. Overall, this inspection concluded without new regulatory observations, reflecting Pfizer's efforts to enhance its clinical trial monitoring and compliance.