FDA 483 - MassBiologics - September 01, 2022

An FDA inspection of MassBiologics in Boston, MA, a vaccine manufacturer, revealed significant deficiencies across three observations. These issues include inadequate aseptic filling procedures, disorganized and potentially compromised storage of in-process and finished product samples, and a general lack of cleanliness and sanitation in manufacturing and storage facilities. The findings indicate a need for improved contamination control and adherence to good manufacturing practices.