F.D.A. Cites Failures at Plant Where J.&J. Doses Ruined

Federal regulators on Wednesday released extremely critical results from their inspection of a Baltimore plant that was forced to dispense up to 15 million doses of Johnson & Johnson’s coronavirus vaccine and ordered all production to be temporarily suspended.

The Food and Drug Administration cited a number of shortcomings in the huge facility operated by Emergent BioSolutions. The inspection was triggered by reports that Emergent employees had contaminated a batch of Johnson & Johnson cans with the harmless virus used to dispense the AstraZeneca vaccine, which is also manufactured at the factory.

Violations included failure to properly disinfect the facility and its equipment, as well as failure to follow appropriate procedures to prevent contamination of the cans and to ensure the strength and purity of the vaccine produced there. In a 12-page report, the inspectors listed a total of nine violations, ranging from the design of the building to improperly trained staff. The inspection ended on Tuesday.

In a statement, the FDA stated that it did not authorize Emergent to distribute doses of Johnson & Johnson vaccines and that no vaccine manufactured at its facility has been approved for use in the United States.

AstraZeneca’s vaccine is not yet approved for use in the United States, and all of the Johnson & Johnson doses administered in the country to date have been manufactured overseas. At the agency’s request, all production in the factory was discontinued.

“We will only allow a product to be released when we are sure that it meets our quality expectations,” said Dr. Janet Woodcock, Acting Commissioner of the FDA, and Dr. Peter Marks, the agency’s lead vaccine regulator.

The agency said it was working with Emergent to fix the issues.

Inspectors criticized Emergent’s response to last month’s discovery that the Johnson & Johnson cans were contaminated with the AstraZeneca virus. The incident “has not been fully investigated,” they wrote.

For example, Emergent did not monitor the movement of workers between the zones where each vaccine was made. “There is no guarantee that other batches have not been contaminated,” they said.

The inspectors found that workers frequently switched between the AstraZeneca and Johnson & Johnson production zones without documenting that they had showered and changed their clothes as needed. For example, one day more than a dozen employees moved from one zone to another, but only one documented the showering, they said.

Workers also failed to properly handle production waste, creating a risk of contamination in the warehouse where the raw materials were stored, the inspectors found. They also cited peeling paint, crowded conditions, and other facility issues.

Emergent said in a statement on Wednesday: “While we are never satisfied with defects in our manufacturing equipment or processes, they can be corrected and we will take swift action to correct them.” In its own statement, Johnson & Johnson said it had already stepped up its oversight of Emergent, its subcontractor, and that it would “ensure that any FDA observations are promptly and comprehensively addressed”.

One major change has already been made: AstraZeneca is no longer manufactured at the factory, a move federal officials insisted earlier this month to limit the likelihood of cross-contamination with Johnson & Johnson’s vaccine.