BOSTON — The U.S. Food and Drug Administration announced on Wednesday that after a completed inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 vaccine, they cited several observations concerning whether the facility’s processes met the FDA’s requirements and standards.
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The FDA said its inspections were thorough after reviewing the quality of manufacturing procedures. Those included records, staff training, facility operations, drug production, testing, and the systems to ensure the product’s quality.
At the agency’s request, Emergent BioSolutions has agreed to pause the new production of the Johnson & Johnson COVID-19 vaccine while it works with the FDA to resolve problems found in the inspection process. For vaccines already manufactures, the FDA said the products will undergo additional testing and will be thoroughly evaluated to ensure the quality of the product before distributing it.
The FDA said that as it continues to observe the conditions of the company, it will be able to help identify a path for Emergent BioSolutions to take to remedy the issues.
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Officials also added that this action is unrelated to the ongoing evaluation by the FDA and U.S. Centers for Disease Control and Prevention of the rare cases of a specific type of blood clot reported in a small number of individuals after receiving the Johnson & Johnson COVID-19 Vaccine.
For more information on the FDA’s inspection into Emergent BioSolutions, click here.
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