Baltimore plant with contaminated Johnson & Johnson vaccines had multiple failures, unsanitary...
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Kaitlan Collins
@kaitlancollins
The FDA released a scathing inspection report that cites multiple failures at the Emergent BioSolutions manufacturing plant in Baltimore that ruined 15 million doses worth of raw Johnson & Johnson coronavirus vaccine.
Baltimore plant with contaminated Johnson & Johnson vaccines had multiple failures, unsanitary...
washingtonpost.com
7:44 AM · Apr 21, 2021
https://www.washingtonpost.com/business/2021/04/21/fda-johnson-johnson-vaccine-inspection/
The Food and Drug Administration Wednesday released a scathing inspection report that cites multiple failures at the Emergent BioSolutions manufacturing plant in Baltimore that ruined 15 million doses worth of raw Johnson & Johnson coronavirus vaccine.
The FDA said Emergent failed to conduct a thorough review of the incident, in which vaccine ingredients from an AstraZeneca coronavirus vaccine were mixed with the Johnson & Johnson product.
The report says Emergent has identified a batch of media used to manufacture Johnson & Johnson vaccine as the most likely cause of the cross-contamination. But the report cites a ``failure to conduct thorough investigations into unexplained discrepancies.''
It also cites a number of unsanitary conditions at the plant. It said waste was not decontaminated and that inspectors found peeling plant in sensitive manufacturing areas.
In another finding, the report said a review of security camera footage showed employees failing to follow proper procedures in the handling of medical waste.
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None of the vaccines from Emergent have been administered.