FDA 483 - Brammer Bio MA, LLC - February 10, 2021

Brammer Bio MA, LLC, a viral vector manufacturer in Somerville, MA, was cited for a significant quality control failure. The firm shipped rejected and un-dispositioned lentiviral vector material to a client without the knowledge or approval of its quality unit. This lapse involved multiple lots of material over several months, indicating a failure in ensuring proper disposition and authorization before product release.