The inspection was initiated after reports had come to the surface that workers at the plant had accidently contaminated J&J doses with the virus from the AstraZeneca vaccine, which is also manufactured there.
Johnson & Johnson can’t catch a break these days when it comes to breaking into the COVID-19 vaccine market in the United States. On Wednesday, federal regulators ordered the Baltimore plant, operated by Emergent BioSolutions, where nearly 15 millions doses of the Johnson & Johnson vaccine were ruined to temporarily stop all of its production.
This follows on the heels of a decision last week by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention to pause administering the vaccine at federal cites because of 6 US cases of rare blood clot disorders that it may have caused.
Regarding the Baltimore site, the FDA issued some highly critical findings and cited a series of shortcomings at the plant in their decision. The inspection was initiated after reports had come to the surface that workers at the plant had accidently contaminated J&J doses with the virus from the AstraZeneca vaccine, which is also manufactured at there.
The FDA included 9 violations in their 12 page report, including a failure to properly disinfect the factory and its equipment, a failure to follow proper procedures which are designed to prevent contamination of doses and having improperly trained employees.
For example, the investigators had discovered that employees would often move back and forth between working with the J&J vaccine and the AstraZeneca doses, without documenting that they had taken the necessary precautions to ensure integrity and cleanliness.
The FDA finished their inspection of the pant on Tuesday.
Noted in the report is that the FDA has not authorized the plant to distribute any does of the vaccines, and that none from the pant have thus far been released for use in the country.
“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” Janet Woodcock, the FDA’s acting commissioner said.
Changes have already begun at the plant, including that they will no longer be manufacturing the AstraZeneca vaccines, as was insisted on by federal officials to limit the potential for cross-contamination.