FDA Examination Intel: Substandard Conditions at Contractor’s Plant for J&J Vaccine Production Have Been Reported

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The FDA examined the Emergent BioSolutions manufacturing facility after the production there was paused last Friday. And the FDA was the one to order the pause, due to “potential quality issues.”

“The FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards,” the FDA wrote in a statement.

After the examination, it was stated that the FDA has not authorized either the manufacture either the distribution of J&J components at the facility. Also, none of the CCP vaccines that were produced there haven’t been distributed in the States, so far. The testing will continue, and we will update as soon as we get new information.

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Johnson & Johnson didn’t remain quiet regarding the whole situation.

“Johnson & Johnson will exercise its oversight authority to ensure that all of FDA’s observations are addressed promptly and comprehensively. The Company will also redouble its efforts as it continues to work toward securing Emergency Use Authorization in the United States for drug substance manufactured at Emergent Bayview as quickly as possible,” the company stated.

The J&J vaccine has been stopped due to research that found it resulted in blood clots.

“Out of an abundance of caution, the FDA and CDC recommended a pause in the use of the Johnson & Johnson (Janssen) COVID-19 vaccine while we review data from six reported cases in the U.S. of a rare and severe type of blood clot in people who received the vaccine,” the FDA wrote on April 13.

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Ava Garcia

A small town girl, dreaming big, expecting to change the world with presenting the truthful events of the world today. Law degree with a master in criminology, and a devoted journalist for over 7 years, and counting. "The pen is mightier than the sword."

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