The Food and Drug Administration reported significant sanitation issues at the Emergent BioSolutions manufacturing plant where 15 million doses of the Johnson & Johnson coronavirus vaccine were ruined.
“Emergent is committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified,” the Baltimore plant said on Wednesday. “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.”
The FDA’s inspection of the Emergent BioSolutions facility revealed that the plant “is not maintained in a clean and sanitary condition.” The 13-page report described “unsanitary” conditions, such as poor decontamination procedures and unsafe disposal of manufacturing waste that the agency said has the potential to infect other parts of the manufacturing warehouse.
The FDA also found damaged floors, peeling paint, and wall damage that impede the staff’s ability to disinfect the plant where the vaccines are made.
JOHNSON & JOHNSON PAUSE MAKES IT HARDER TO VACCINATE RELUCTANT, HARD-TO-REACH PATIENTS
“There is no assurance that other batches have not been subject to cross-contamination,” the FDA said.
The FDA directed Emergent BioSolutions to pause manufacturing earlier this week while it investigates the plant responsible for contaminating 15 million doses meant to go to other countries.
The plant was initially tasked with manufacturing the Johnson & Johnson vaccine and the AstraZeneca vaccine, even though AztraZeneca’s hasn’t been authorized for use in the United States. The Biden administration directed Johnson & Johnson to take over manufacturing at the plant, pushing AstraZeneca’s manufacturing to resume elsewhere.
JOHNSON & JOHNSON VACCINE SHIPMENTS TO BE DELAYED AFTER PRODUCTION MIX-UP RUINS 15M DOSES
The FDA’s inspection completed on Tuesday is unrelated to a handful of reports of rare and severe blood clotting in people who had received the single-shot vaccine. Federal regulators recommended a pause last week on the Johnson & Johnson vaccine administration until the panel of vaccine experts at the CDC charged with making recommendations on vaccines concludes that the cases of dangerous clotting are not associated with the shots.
