FDA hits Emergent BioSolutions facility with 'significant violations'

In a volley between the FDA and Emergent BioSolutions over the biotech's Baltimore facility, the agency said Emergent was "inadequate" in its efforts to fix drug manufacturing errors. 

The FDA sent a warning letter to one of Emergent's businesses, Cangene BioPharma, on Aug. 10. In April 2021, the FDA inspected the facility and found contamination failures after multiple customer reports and subsequent investigations found metal particulates in Cangene's drugs. Misuse of tray units was responsible for the metal contamination, the investigation found. 

Emergent then met with the agency in October 2021 to hash out a solution for its "significant violations," but the FDA said the biotech company has since failed to meet those promises.

"Your response is inadequate," the FDA said in the Aug. 10 letter. "You did not provide substantive evidence that your tray units are suitable for their intended purpose."

The warning letter listed three observations from its investigation:

  • An operator was leaning into the aseptic filling cabinet which caused blockage of the unidirectional airflow over open glass vials. Notably, there was no subsequent clearance of the vials on the line exposed to potential contamination hazard.
  • An operator left the filling cabinet door open for an excessive period.
  • Poor practices by operators when manipulating vial tray containers and the [redacted] used for charging these trays.

The FDA told Emergent to respond with the company's corrective action and preventive action plan, as well as an independent review of its manufacturing process and aseptic processing. 

Emergent responded to the letter Aug. 12, but the full report wasn't published until Aug. 16 because the FDA publishes warning letters every Tuesday. 

"Biopharmaceutical manufacturing is complex, and the stakes are high," Emergent said in an Aug. 12 press release. "That is why we have made significant investments to upgrade our physical capabilities and are focused on strengthening our culture of quality and compliance. This is a process that doesn't happen overnight, but one to which we are committed."

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