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US vaccine maker halts production of J&J vaccine after failed inspection – Health Dept

Washington: Emergent BioSolutions, a US vaccine manufacturer hired to make the coronavirus vaccine developed by Johnson & Johnson (J&J) stopped production after a multi-day inspection found unsanitary conditions and other deficiencies, the Food and Drug Administration (FDA) said.

“During an inspection of Emergent BioSolutions that ended Tuesday, the FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards. These observations are outlined in our inspection closeout report, also known as a “FDA Form 483,” the health agency said in a press release on Wednesday.

In addition to unsanitary conditions, the FDA inspection report cited the facility for inadequate size to meet contracted production goals, inadequate written procedures and substandard employee training.

Emergent BioSolutions halted production while it works with the FDA to resolve potential quality issues, the release said.

Emergent BioSolutions made headlines late March for ruining 15 million doses of the J&J vaccine by mixing ingredients used to make another vaccine developed by AstraZeneca.

No J&J vaccine doses produced by the facility have been distributed, the FDA said.

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