FDA EIR - Pfizer Inc. - August 11, 2009

On August 11, 2009, the FDA conducted a pre-approval and method validation inspection at Pfizer Laboratories Division of Pfizer Inc. in Groton, CT. The inspection, requested by CDER EES, specifically focused on the control testing laboratory's role as a proposed alternate finished dosage stability testing site for Lomotil Tablets (NDA 12462/043), manufactured by GD Searle LLC. Additionally, a general Good Manufacturing Practice (GMP) inspection was performed on the control testing laboratory using CP 7346.832. The inspection verified the successful analytical method transfer exercise for Lomotil tablets from Pfizer's Caguas, PR facility to the Groton, CT site, with test results for assay, degradants, and dissolution meeting specifications. The Groton laboratory possesses the necessary equipment and controlled substance license for handling Schedule II materials, like the diphenoxylate hydrochloride reference standard, which was a key factor in selecting this site. Crucially, the inspection revealed no deficiencies in the laboratory operations or the method transfer process. Consequently, no FDA-483 Inspectional Observations were issued, and no recommendations or corrective actions were required from the facility. This indicates the site was found to be in satisfactory compliance with regulatory expectations for its intended stability testing role.