FDA EIR - bluebird bio, Inc. - March 09, 2021

bluebird bio, Inc. underwent an FDA Pre-License Inspection from March 1 to March 9, 2021, at its Cambridge, MA facility. This inspection, conducted under Compliance Program Guide 7345.848 for Biological Products, specifically focused on the anti-BCMA02 CAR Lentiviral Vector (LVV), a critical component for idecabtagene vicleucel (Ide-cel) used in multiple myeloma therapy, under BLA STN 125736/0. The review covered the company's Quality, Laboratory Control, and Facilities and Equipment Systems. At the inspection's conclusion, the FDA issued a Form 483, detailing four significant observations. These included inadequate quality oversight of operations, a failure to thoroughly investigate unexplained discrepancies, inconsistent scheduling and performance of preventative maintenance, and a lack of assurance regarding the exactness, completeness, and security of backup electronic data, specifically concerning recovery verification. These issues raise concerns about the firm's control over critical manufacturing components and data integrity. bluebird bio, Inc.'s management committed to providing a formal response to the FDA within 15 business days, outlining their corrective actions to address the observed deficiencies.