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

Pfizer Manufacturing Austria GmbH, located in Orth An Der Donau, Austria, was inspected by the FDA from November 9 to November 17, 2023. The inspection revealed significant issues with the company's data management and record-keeping practices. Specifically, the firm failed to maintain original hardcopy or alternative data systems that are exact, complete, and secure from alteration or loss. Records stored at an off-site facility were not consistently retrievable, and verification checks were not conducted to ensure proper database entry. Additionally, the firm's procedures for data management were found to be deficient, lacking assurance of chain of custody and accuracy of GMP production and laboratory data.

The inspection was conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, specifically Section 704(b), which mandates the reporting of objectionable conditions. Pfizer is required to address these issues by implementing corrective actions to ensure compliance with FDA regulations. This includes improving data management procedures, ensuring the secure and accurate storage of records, and conducting thorough verification checks to prevent future discrepancies. The company has initiated a supplier complaint, which remains in progress, to address these concerns.