FDA 483 - Baxalta Belgium Manufacturing SA - November 22, 2024

Baxalta Belgium Manufacturing SA, a plasma derivative manufacturer, was inspected by the FDA. The inspection revealed deficiencies in batch production and control records, specifically concerning the documentation of major equipment identity and the review of filling line alarms for products like GAMMAGARD Liquid, Cuvitru, and Glassia. These issues indicate a lack of adequate record-keeping and quality control practices.