FDA 483 - MassBiologics - November 19, 2019

MassBiologics, a vaccine manufacturer in Boston, MA, received an FDA Form 483 citing significant deficiencies across its operations. The observations highlight inadequate validation of aseptic and sterilization processes, insufficient control procedures for manufacturing, and a failure to thoroughly investigate discrepancies and implement timely corrective actions. Additional concerns include poor data integrity, lack of proper supplier qualification, and non-compliance with change control and complaint handling procedures.