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FDA report finds significant problems at Baltimore plant that contaminated Johnson & Johnson COVID vaccine

An inspection by the U.S. Food and Drug Administration found significant sanitation and procedural problems at the East Baltimore plant that ruined 15 million doses of the Johnson & Johnson COVID-19 vaccine.

Released Wednesday, the new documents shed light into Emergent BioSolutions’ continued lack of federal authorization to distribute the vaccine it’s produced. Inspectors found cleaning and sterilization failures; lack of adherence to protocols; and potential cross-contamination in multiple areas.

The FDA has instructed Emergent to pause new production while it works with the agency to correct the documented problems. But the federal regulators did not offer a timeline as to when the corrections should be implemented.

APR 21, 2021

https://www.nydailynews.com/

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