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by Brew Editors8:32 amApr 1, 20210

Emergent BioSolutions had safety citations prior to Baltimore facility vaccine mistakes

The FDA cited the company for poorly trained employees, cracked vials, mold and more, the Associated Press reports

Above: A “mix up” at this East Baltimore factory ruined millions of doses of Johnson & Johnson coronavirus vaccine. (emergentbiosolutions.com)

The company whose Baltimore factory is at the center of manufacturing problems that caused Johnson & Johnson to discard millions of doses of coronavirus vaccine was flagged numerous times for federal quality control violations in the past, the Associated Press is reporting.

Emergent BioSolutions, based in Gaithersburg, had been scheduled to deliver 100 million doses of the J&J vaccine next month.

“The company has been cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold around one of its facilities,” the AP story says, citing records covering inspections since 2017 that it obtained through the Freedom of Information Act.

On the same day last year when Johnson & Johnson was touting its partnership with Emergent, the FDA was citing the company for failing to train employees “in the particular operations they perform as part of their function and current good manufacturing practices,” AP noted.

Current Supply Not Affected

The report follows the New York Timesdisclosure yesterday that “a factory mix up” at the company’s Bayview facility in East Baltimore led to as many as 15 million doses being discarded and delayed federal authorization of the plant’s production line.

The mistakes by Emergent do not affect any Johnson & Johnson doses that are currently being delivered and used nationwide, the Times noted, pointing out that all those doses were produced in the Netherlands, where operations have been fully approved by federal regulators.

The AP documents the increased lobbying spending by the company during the Trump administration and a scramble to upgrade its Bayview facility, described as “a contract testing facility that did not manufacture products for distribution.”

Johnson & Johnson has acknowledged that one batch of material used in production of the vaccine “did not meet quality standards,” but said it will continue to support efforts to get emergency authorization for the Baltimore facility.

AP said Emergent declined to comment on the report.

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