Emergent BioSolutions Receives NAI Status for Baltimore Bayview Manufacturing Facility
GAITHERSBURG, Md., March 25, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) 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.
- GAITHERSBURG, Md., March 25, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) 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).
- “We will continue to put quality and compliance first in our manufacturing operations to ensure we’re delivering high quality products to our customers and patients.”
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.