FDA 483 - MassBiologics South Coast - August 12, 2024

An FDA inspection of MassBiologics South Coast in Fall River, MA, revealed six significant observations. The firm exhibited deficiencies in environmental monitoring practices and the timely closure of deviations and investigations. Additionally, the facility was not maintained in a good state of repair, and standard operating procedures lacked sufficient detail or were not followed, alongside issues with document management.