FDA Issues Warning to Emergent Biosolutions

Emergent Biosolutions has received a warning from the US Food and Drug Administration (FDA) regarding concerns about its Baltimore manufacturing plant, as disclosed in an SEC filing last week. The agency notes that there are serious issues in the facility’s aseptic processing and its cleaning and upkeep of equipment that prevents drug product contamination from particulates.

According to Tyler Patchen, “The warning letter from the FDA said that most of the tray units at the facility have suffered apparent damage and were also inadequate for use in sterile drug production. Emergent also lacked any specifics regarding its document activities for the inspection, identification, segregation, evaluation, repair or retirement of defective tray units. While Emergent stated to the FDA that it improvements to the program monitoring aseptic processing personnel behavior and classroom training on aseptic behaviors the US regulator found that that response was not adequate.”

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(Source: Endpoints News, August 15th, 2022)