FDA 483 - Brammer Bio MA, LLC - August 30, 2023

An FDA inspection of Brammer Bio MA, LLC in Cambridge, MA, a cell and gene therapy API manufacturer, revealed significant deficiencies in facility and equipment maintenance and cleanliness. Inspectors observed broken tiles, discoloration, rust, chipping paint, and unsealed openings in manufacturing areas. Additionally, the firm failed to adequately segregate raw materials and cleaning supplies in the holding dock, raising concerns about potential mix-ups and contamination.