FDA 483 - Brammer Bio MA, LLC - December 19, 2023

An FDA inspection of Brammer Bio MA, LLC in Somerville, MA, from December 13-19, 2023, identified one significant observation. The firm failed to follow its written production and process control procedures for HEPA filter certification. This lapse involved incorrect certification frequency for a Laminar Air Flow hood used in manufacturing, indicating a deviation from established quality control protocols.