Camden close out: Emergent turns page on noncompliance chapter

Emergent BioSolutions says GMP operational issues have been resolved 15 months after its Baltimore, Maryland facility received a US FDA warning letter.

According to Emergent, significant investment and upgrades at the Camden, Baltimore plant drove an expeditious close out to the issues highlighted by the US Food and Drug Administration (FDA) in the letter dated August 2022.

“With respect to our Camden facility in Baltimore, following a re-inspection in July, August of 2023, we received notification from the FDA that we have addressed the matters contained in their August 22 warning letter,” Haywood Miller, interim CEO, said on his firm’s Q3 conference call last week.

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“The FDA has also communicated that both the inspections that began in February 2022 and July, August of 2023 are considered closed.”

The August 2022 warning letter had cited areas of deficiencies in the firm’s contamination prevention measures related to systems for cleaning and maintenance of equipment. Among the issues, the Agency described finding particulates from metal trays and questioned processes and practices surrounding aseptic processing.

Miller said the close out came down to “significant investments” made to upgrade the facility. He added Emergent also “[strengthened] our culture of quality and compliance across the manufacturing network and enterprise, allowing us to close this action expeditiously.”

CFO Rich Lindahl described the close-out letter at Camden as “a testament to the dedication and skill of our quality and operations teams, and position the facility to return to normal operations as we support our existing customers going forward.”

For the third quarter 2023, Emergent saw sales of $271 million. This included $21 million in contract development and manufacturing organization (CDMO) revenues. The firm said earlier this year it plans to step away from its CDMO business in order to strengthen its core business.