Pfizer Manufacturing Belgium NV – FDA EIR, Jun 28, 2024

An FDA pre-approval inspection (PAI) of Pfizer Manufacturing Belgium NV (Pfizer Puurs, Puurs-Sint-Amands, Belgium) was conducted from June 24 to June 28, 2024. The inspection supported the review of a Prior Approval Supplement for a new dual-chamber Act-O-vial (AOV) presentation of the respiratory syncytial virus (RSV) vaccine and sterile water-for-injection diluent for the U.S. market. The PAI was performed under Compliance Program Guidance Manual-45 Biological Drug Products 7345.848, covering Quality, Facility and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control systems. Significantly, no FDA Form 483 was issued at the inspection's conclusion. However, discussion items were conveyed to Pfizer Puurs management. One specific deficiency noted was the inadequacy of the filling line's cleaning qualification to support multi-product use for the new RSV AOV presentation. In response, Pfizer Puurs committed to dedicating this specific filling line for RSV products and to perform adequate cleaning qualification prior to introducing any new non-RSV products.