A Statement on Emergent’s Camden Manufacturing Facility Regulatory Status
GAITHERSBURG, Md., October 5, 2023 – Emergent (NYSE: EBS) received important communications from the U.S. Food and Drug Administration (FDA) regarding its Camden drug product manufacturing facility in Baltimore, Maryland.
This week, FDA sent Emergent a “Warning Letter close-out letter,” regarding its Camden facility, stating that “it appears that [Emergent has] adequately addressed the violations contained in the Warning Letter” originally issued in August 2022. FDA has also communicated to Emergent that the inspection classification for its Camden facility is “Voluntary Action Indicated” and that the inspection is considered “closed.” This is regarding an FDA inspection from February 2022, which classified the Camden facility as “Official Action Indicated.”
Emergent is committed to ensuring continued compliance with Current Good Manufacturing Practice requirements and remains steadfast in manufacturing and delivering high-quality products across its global network of manufacturing facilities.
Safe Harbor Statement
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