Pfizer Inc. – FDA EIR, Feb 2, 2007

The FDA conducted an establishment inspection of Pfizer Laboratories Div. of Pfizer Inc.'s Groton, CT facility from February 2 to February 7, 2007. The inspection, which covered the manufacture of bulk active pharmaceutical ingredients (APIs) and control laboratory operations, was conducted under C.P. 7356.0002 and C.P. 7356.002P, utilizing ICH Q7A guidance for finished APIs. Notably, no formal objectionable conditions or FD-483 observations were issued during this inspection. However, the inspection team identified an area concerning the reuse of certain intermediate product containers, specifically noting a lack of explicit documentation in batch records for the reuse of "lever pack containers." In response to this observation, Pfizer management voluntarily and immediately revised their operating procedure (OSP-MFG-104-07) during the inspection. This revised procedure now explicitly prohibits the reuse of these specific containers for subsequent manufacturing, requiring them to be discarded after initial use. The Groton facility is in the process of ceasing all API manufacturing by 2008, transferring production to other global Pfizer sites, but the control laboratory operations will continue at this location.