FDA EIR - Pfizer Ireland Pharmaceuticals Unlimited Company - November 12, 2019

An FDA inspection of Pfizer Ireland Pharmaceuticals in Clondalkin, Dublin, Ireland, took place from November 4 to November 12, 2019. The inspection, conducted under the Team Biologics FY2020 work plan and in accordance with CP 7345.848 for Biological Drug Products (CBER), focused on commercially licensed products Prevnar 13, Trumenba, and Aluminum Phosphate Suspension, which operate under US Government License No. 3. The inspection culminated in a Form FDA 483, detailing two significant observations. The first observation, citing a "Failure to submit biological deviation reports" (21 CFR 600.14(a)(1)), pertained to approximately ten confirmed US complaints received between September 2018 and October 2019. These complaints involved the presence of particles, identified as poorly dispersed aluminum phosphate, in Prevnar, which contradicted the product's specified "Homogeneous, white suspension" appearance. The second observation (21 CFR 211.192) highlighted "a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed." This encompassed an inadequate evaluation of a test failure, where all relevant alarms and potential elevated levels were not fully assessed. Furthermore, a Biological Product Deviation Report concerning an atypical rubber component found in Prevnar batches was deemed incomplete for not explicitly stating that the rubber formulation contained an ingredient inconsistent with the registered material. Pfizer management acknowledged the observations, agreeing to submit a written response within 15 working days. The FDA informed the company of potential regulatory actions, should non-compliance persist.