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Company at center of recent J&J vaccine woes has series of FDA citations

Johnson and Johnson still plan to deliver 100 million vaccines to the U.S. by the end of May.

Updated: April 1, 2021 - 10:58pm

The Facts Inside Our Reporter’s Notebook

The company that recently caused supply and distribution problems for the Johnson & Johnson COVID-19 vaccine has been found to have several citations from the Food and Drug Administration for quality control issues.

On Wednesday, Johnson & Johnson announced that a recent batch of vaccines failed a quality check and couldn't be used. The pharmaceutical company also said one of the vaccine ingredients made by the company Emergent BioSolutions did not meet Johnson & Johnson quality standards and therefore could not be used, according to the Associated Press.

On Thursday, the Associated Press reported Emergent Bio Solutions had been cited previously by the FDA for several problems, including cracked vials, mold in one of its facilities and poorly trained employees. 

The wire service obtained the information through the Freedom of Information Act and found problems dated back to 2017.

Johnson & Johnson did not say how many vaccines were part of the ruined batch, nor did the company say how the setback will impact its plan to roll out 100 million vaccines in the United States by the end of May.

Emergent Solutions is only one of about eight companies that Johnson & Johnson is using to speed up its vaccine rollout.

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