FDA 483 - MassBiologics

MassBiologics, a vaccine manufacturer in Boston, MA, was cited for multiple deficiencies during an FDA inspection. The firm exhibited significant issues with its deviation investigation process, including inadequate documentation, unmonitored corrective and preventative actions, and insufficient root cause analysis. Additionally, the inspection revealed a lack of written procedures for aseptic operations and a failure to certify HEPA filters according to established SOPs.