Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) has listed ?No Action Indicated? or NAI status classification for the company's Baltimore Bayview manufacturing facility. Based on this outcome, the Baltimore Bayview facility is considered to be in an acceptable state of compliance with regard to current good manufacturing practices (cGMP).

Emergent is committed to ensuring continued compliance with cGMP requirements and remains steadfast in manufacturing and delivering high-quality products for the customers, partners, and patients it serves. The result of obtaining NAI status in Bayview is a continuation of Emergent?s strong commitment to quality and compliance. In 2023, Emergent manufacturing facilities were successfully inspected by five regulatory agencies across the globe and five other inspectional bodies for 18 inspections, including three by the FDA that resulted in NAI or VAI status.

This includes the closing of the Baltimore - Camden Warning Letter in 14 months.