FDA 483 - Pfizer Manufacturing Austria GmbH - November 17, 2023

Pfizer Manufacturing Austria GmbH, a vaccine manufacturer in Orth An Der Donau, Austria, was cited for deficiencies in maintaining original hardcopy and alternative data systems during an FDA inspection from November 9-17, 2023. The firm failed to ensure records were exact, complete, and secure, with numerous original files missing from their archiving database and inadequate verification checks. Additionally, data management procedures were found to be deficient, impacting the chain of custody and accuracy of GMP production and laboratory data.