High-profile problems at Emergent BioSolutions’ massive Bayview plant in Baltimore led to its temporary closure last year and forced the contract manufacturer to discard more than 500 million doses of COVID-19 vaccines.
Now Emergent’s other plant in Baltimore—its smaller fill-finish Camden facility—has been pinged for deficiencies in maintenance and cleaning of equipment. Emergent revealed in an SEC filing that it had received a warning letter from the FDA on Aug. 10.
The regulator cited “particulate contamination issues” and a failure to establish written procedures that are designed to prevent drug product contamination. The letter noted that Emergent’s procedure for maintenance of tray units was inadequate and that most of them were damaged.
In its SEC filing, Emergent said that after the FDA inspected the site in February of 2022, it had hired a third party for review and oversight. But in its warning letter, the regulator “strongly” recommended hiring a CGMP consultant to help Emergent meet requirements. The company has 15 days to respond with its remediation plan.
An Emergent spokesperson referred to a statement posted on its website.
"Biopharmaceutical manufacturing is complex, and the stakes are high," Emergent states. "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 isn’t the first time Emergent has been admonished for problems at the Camden site. The FDA cited “similar deviations” from an inspection it conducted last April.
“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” the FDA wrote.
In 2018, Emergent revealed that it was investing $50 million in its Camden site, adding 45,000 square feet and 60 jobs by 2021. The company’s stated goal at that time was to reach $1 billion in annual revenue.
It achieved that standard in 2019. And then, with the help of lucrative government contracts to produce COVID vaccines, Emergent reported revenue of $1.56 billion in 2020 and $1.79 billion last year.
This year the company expects to generate between $1.15 billion and $1.25 billion, it said in reporting second quarter earnings.