bluebird bio, Inc. – FDA 483

An FDA inspection of Bluebird bio, Inc. in Cambridge, MA, a contract test laboratory, revealed significant deficiencies in quality oversight, including poor sample handling, untimely testing and disposition of lentiviral vector batches, and inadequate documentation. The inspection also cited incomplete investigations, a failure to perform required preventative maintenance on temperature-controlled units, and a lack of verification for electronic data backup and recovery. These observations highlight systemic issues in the firm's quality control and data integrity practices.