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

An FDA 483 inspection conducted at Pfizer Manufacturing Austria GmbH, a vaccine manufacturer, from November 9 to November 17, 2023, revealed significant deficiencies in data management and record-keeping practices. The primary observation concerned the company's failure to maintain original hardcopy or alternative data systems that are exact, complete, secure, and protected from alteration, erasure, or loss. Specifically, the inspection found that numerous original GxP-relevant documents, including quality, production, and laboratory records sent to an off-site archiving facility, were not properly maintained or retrievable. An internal search revealed that 93 file folders were unavailable in the archiving database, including high-risk batch-related documentation for a vaccine substance. Despite an internal investigation concluding no product impact, the absence of these critical records represents a severe data integrity concern. Furthermore, Pfizer Manufacturing Austria GmbH does not scan or electronically store backups of original paper-based records, and its procedures for interim storage and archiving of GxP documents were deemed deficient. The firm's Quality Unit also failed to ensure the chain of custody and accuracy of GMP production and laboratory data from generation through the product's shelf life. These observations require immediate attention and corrective actions from Pfizer to comply with regulatory expectations for data integrity.