FDA blasts troubled COVID-19 vaccine producer Emergent for quality control and cleanliness issues

emergent
Among the issues cited by the FDA, Emergent failed to properly investigate an ingredient mix-up that cost the CDMO up to 15 million doses of Johnson & Johnson's COVID-19 vaccine. (Emergent)

The FDA’s latest inspection of Emergent BioSolutions’ troubled Baltimore plant has raised fresh concerns about the contract manufacturer's ability to produce COVID-19 vaccines. Emergent, for its part, says it's working to get the plant up to speed.

The regulator, which completed the inspection on Tuesday, cited Emergent for a raft of cleanliness and quality control issues, including its failure to properly investigate the ingredient mix-up that ruined up to 15 million doses of Johnson & Johnson’s pandemic shot. The blunder prompted the government to put Johnson & Johnson in charge of production at Emergent’s Baltimore facility, though as of Monday, manufacturing there has been put on pause.

"Emergent is committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified," a company spokesperson said via email. 

"We deeply value the relationship we have with our manufacturing partners and with the FDA," the spokesperson added. "The FDA’s feedback will help continue to improve and strengthen the supply chain for Johnson & Johnson’s vaccine. While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them."

As far as the vaccine drug substance mix-up is concerned, Emergent failed to review workers’ movements in and around the facility as a possible source of contamination, the FDA said. The company also neglected to upgrade its sanitary standards after the mistake, and it failed to consider whether its raw material storage was below par, the agency said.

In a stunning finding, the FDA said Emergent can't be sure there weren't other instances of contamination.

“There is no assurance that other batches have not been subject to cross-contamination,” the FDA said in its report.

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Unsanitary conditions also featured in the FDA's findings. The CDMO didn’t properly decontaminate waste produced during its vaccine manufacturing runs and transported waste through its warehouse before disposal. That process could “contaminate the warehouse and adjacent areas,” the regulator said.

Paint was also chipping off the walls of controlled corridors surrounding Emergent’s manufacturing rooms, the FDA said. In one of the areas where Emergent was filling vaccines, investigators discovered paint flecks, debris and “black residue” on the floor, plus “brown residue” on the wall.

Plus, the agency raised concerns about the size of the plant in comparison to the amount of work it's taking on. Security cameras revealed that Emergent’s warehouse was at several points overcrowded with materials queued up for production and quality control.

Other areas were congested with carts, drug substance containers and other equipment, making it difficult to move without bumping into things, the FDA said. Some spaces were too small for workers to use a pallet jack to move large amounts of material, and on April 12 and 13, investigators said they observed workers “pushing and pulling” large containers along the floor to move them into the warehouse.

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Among the FDA's other findings, the agency said workers at the plant weren’t following written procedures to prevent cross-contamination. Emergent itself failed to adequately train its employees on a range of manufacturing operations, the FDA said. Employees were seen toting unsealed bags of medical waste from manufacturing spaces and, in one instance, they were observed “throwing unsealed bags of special medical waste into the service elevator accessing the warehouse corridor.”