FDA 483 - Baxalta US Inc. - July 01, 2021

An FDA inspection of Baxalta US Inc. in Social Circle, GA, identified two significant issues. The firm failed to maintain complete laboratory records for stability testing, specifically regarding purity determinations for Gammaguard Liquid 10% IGI, and did not report missed stability tests to the Agency. Additionally, procedures for preventing objectionable microorganisms and for remedial cleaning after mold recovery in manufacturing areas for Gammaguard Liquid and Flexbumin were found to be inadequate or not followed.