Company involved in 15 million discarded doses of the J&J vaccine has history of quality control violations

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Emergent Biosolutions was cited by the FDA on quality control issues, including mold and cracked vials.

The mishap was due to human error, according to The Times, when workers at the plant mixed up the vaccine ingredients. The Food and Drug Administration is currently investigating the incident.

In a recent inspection, the FDA cited the company's Bayview plant on "data integrity concerns" after a review found that the facility had failed to ensure that electronic testing data "was protected from deletion or manipulation," the AP reported.The Bayview plant was criticized for not following proper testing and lab procedures, according to the report.

A spokesman for the FDA told the AP that the agency "cannot comment on any particular company or any potential or ongoing compliance matters." Despite the factory mixup, the Biden administration still expects to reach its goal of having enough vaccines to make every American adult eligible for a vaccine by the end of May, The Times reported.

 

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