FDA EIR - Pfizer Manufacturing Belgium NV - July 02, 2021

This FDA establishment inspection report details a pre-license inspection of Pfizer Manufacturing Belgium NV, located in Puurs, Belgium. The inspection, conducted from June 24 to July 2, 2021, evaluated the facility for the manufacturing, fill/finish, and labeling/packaging of COMIRNATY™ (COVID-19 Vaccine) under a Biologics License Application (BLA). The regulatory framework for this inspection falls under the FDA's oversight for biological products. Significantly, the inspection concluded without the issuance of an FDA Form 483, "Inspectional Observations," indicating no major regulatory violations were identified by the agency. The inspection covered critical systems including Quality, Facilities/Equipment, Production, Materials, Packaging/Labeling, and Laboratory Control. While no formal FDA observations were issued, the company had previously investigated internal deviations, such as batches demonstrating lower than expected potency due to raw material impurities, leading to process revisions. Other internal deviations included issues with a specific assay and non-inspected vials being labeled, prompting internal corrective actions and revisions to procedures as part of their ongoing quality management system.