FDA 483 - Emergent Biosolutions LLC - December 21, 2017

Emergent BioDefense Operations Lansing LLC, a manufacturer of vaccine drug substance in Canton, MA, was cited for significant quality system deficiencies during an FDA inspection. Observations included failures in biological product deviation reporting, incomplete investigations, untimely corrective actions, and inadequate environmental controls. The firm also had issues with facility maintenance, equipment qualification, and documentation practices, indicating a broad range of non-compliance.