FDA 483 - bluebird bio, Inc. - March 20, 2025

An FDA inspection of 2seventy bio, Inc. in Cambridge, MA, identified a significant deficiency in their viral vector testing laboratory. The firm failed to maintain complete laboratory records, specifically regarding the adequate qualification of a DNA plasmid reference standard critical for testing the viral vector used in manufacturing drug product ABECMA. This issue highlights a lack of proper control over essential testing processes and data integrity.