FDA EIR - bluebird bio, Inc. - May 06, 2022

An FDA Good Clinical Practice (GCP) sponsor inspection was conducted at bluebird bio, Inc. from April 29 to May 6, 2022, in Cambridge, MA. This high-priority, surveillance inspection, initiated by the FDA's Center for Biologics Evaluation and Research, assessed bluebird bio's responsibilities for clinical study protocols supporting a Biologics License Application, under Compliance Program 7348.810 for Sponsors and Contract Research Organizations. While no formal inspectional observations (Form FDA 483) were issued, two key issues were identified and discussed with company management. Firstly, inactivated log lines in a study database were not appearing in generated casebook PDFs. In response, bluebird bio committed to creating and distributing new casebooks that include these inactivated log lines to clinical sites. Secondly, casebooks for another study lacked an audit trail for source data verification (SDV), meaning there was no clear documentation of who performed the verification and when, thus not adhering to ALCOA principles (attributable, legible, contemporaneous, original, and accurate). Management acknowledged this and explained that while the affected database is decommissioned and cannot be updated, their current platform for new studies incorporates comprehensive audit trails for SDV. No further preventative actions were deemed implementable for the specific historical database issue.