Facility That Ruined 15M J&J Vaccine Doses Found to Be 'Unsanitary' With Black Residue Coating Walls

The FDA has concluded its inspection of the Emergent BioSolutions manufacturing plant in Baltimore where 15 million doses of Johnson & Johnson's COVID-19 vaccine were ruined. Wednesday morning, the agency released a report that included damning observations of unsanitary conditions, including walls that had peeling paint and "brown" and "black residue."

The report also states Emergent failed to conduct a thorough review of the incident, which was caused by vaccine ingredients from an AstraZeneca vaccine getting mixed with the Johnson & Johnson product. The FDA says that insufficient staff training led to the cross-contamination.

Emergent plant
The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021. Getty

Emergent agreed on April 16 to suspend manufacture of the new drug substance and quarantine existing material made at the plant at the request of the FDA while it completed its inspection. Johnson & Johnson was put in charge of manufacturing at the plant in early April by the U.S. government, following the discovery that ingredients from AstraZeneca's shot had contaminated a batch of the Johnson & Johnson vaccine.

The report released today from the FDA also notes that waste produced by making vaccines was not properly decontaminated before being transported through the warehouse. Security camera footage revealed employees in one of the manufacturing areas "throwing unsealed bags of special medical waste into the service elevator." Employees were also seen moving unsealed bags of medical waste from a manufacturing area to the warehouse and not wearing the required protective garments while on the warehouse floor.

Further observations state that Emergent did not properly handle and store viral bulk drug substances to prevent cross-contamination; the company did not have proper procedures for decontaminating waste; and Emergent did not sufficiently train employees. The last complaint comes after personnel were seen entering the manufacturing area during the processing of some bulk drug substance, before then entering other operational rooms without following the proper gowning procedures required.

In a statement released today, the FDA said, "At the agency's request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues. For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution."

The CDC and the FDA called for a pause in the administration of the Johnson & Johnson vaccine last week after six women developed a rare but serious blood-clotting disorder following vaccination. One woman died and one other was hospitalized. Seven million Americans have received the vaccine thus far.

When contacted for comment, Emergent BioSolutions provided Newsweek with a statement that reads, in part: "We deeply value the relationship we have with our manufacturing partners and with the FDA. 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."

Newsweek also contacted Johnson & Johnson for further comment, but has not heard back as of press time.

Updated 4/21/2021, 12:52 p.m. ET: This story was updated to include a statement from Emergent BioSolutions.