A new FDA report said Emergent BioSolutions, which received millions in taxpayer funding, mixed up more doses of J&J and AstraZeneca vaccines than previously thought. The report also said the plant was too small, poorly designed and dirty.
A Johnson & Johnson (J&J) COVID vaccine manufacturing plant where an ingredient mix-up last month resulted in 15 million doses of J&J vaccine being discarded may have contaminated additional doses, according to a report released Wednesday by the U.S. Food and Drug Administration (FDA).
The 13-page report also identified a series of other problems at the Baltimore facility owned by Emergent BioSolutions. Emergent, which in June received $628 million in taxpayer funding through the U.S. Department of Health and Human Services (HHS) to establish the primary U.S. manufacturing facility for J&J’s and AstraZeneca’s COVID vaccines, agreed this week to temporarily shut down operations.
According to the FDA report, “There is no assurance that other batches have not been subject to cross-contamination.” The report also said the plant was “not maintained in a clean and sanitary condition.” Inspectors found peeling paint and unidentified black and brown residue on the floors and walls, as well as a failure to properly decontaminate waste generated during the manufacture of the vaccine.
During an FDA inspection completed Tuesday, the Baltimore plant was found to be too small, poorly designed and dirty. Unsealed bags of medical waste were observed, along with damaged floors and walls that could inhibit proper cleaning, inspectors said.
Emergent also “failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross-contamination of bulk drug substances.”
“I’m shocked — I can’t put it any other way,” said Dr. José R. Romero, chairman of a panel advising the Centers for Disease Control and Prevention that will meet Friday to determine whether to lift the pause on J&J’s vaccine announced last week after reports of blood clots associated with the vaccine. “Inappropriate disinfection, the prevention of contamination — those are significant and serious violations,” Romero said.
In statements Wednesday, the FDA, Emergent and J&J said they were working to resolve the problems at the factory, but gave no indication of how long that would take.