FDA EIR - Pfizer Inc. - September 28, 2022

An FDA inspection was conducted at Pfizer Inc.'s Parsippany, NJ facility from September 26 to September 28, 2022. This inspection, initiated as per the FY’23 workplan and MRA Inspection Request, focused on the control testing laboratory's drug product testing activities, including for Litfulo (ritlecitinib). The regulatory framework for the inspection adhered to Compliance Program 7356.002, Drug Manufacturing Inspections, and comprehensively covered the firm’s Quality and Laboratory Control Systems, alongside overall Good Manufacturing Practices (GMP) operations. The Parsippany site functions as a crucial control testing laboratory for various Pfizer locations, providing scientific and analytical support, including stability study management, sample testing for Active Pharmaceutical Ingredients (API) and marketed products, and investigations into out-of-specification data. Notably, the inspection concluded without identifying any objectionable conditions. As a result, no Form FDA-483, Inspectional Observations, was issued, signifying that the facility was found to be operating in compliance with applicable regulatory standards. Consequently, no specific violations or required actions were documented for Pfizer Inc. stemming from this assessment.