FDA 483 - MassBiologics - July 13, 2010

An FDA inspection of MassBiologics in Boston, MA, revealed several deficiencies related to quality control and documentation. The firm failed to adequately assess product impact for deviations, properly document visual inspections and product complaint investigations, and maintain complete procedures for environmental monitoring and disinfectant effectiveness. Additionally, media fill summaries and annual product reviews were not approved in a timely manner.