The following statement is attributed to Acting FDA Commissioner Janet Woodcock, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research
The U.S. Food and Drug Administration takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and effectiveness.
As part of our regulatory processes for reviewing all manufacturing facilities, the FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine. As Johnson & Johnson announced last month, the FDA has not authorized this facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 Vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S.
The FDA’s inspections are thorough, and these assessments review the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality. 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 FDA’s observations are intended to identify certain conditions observed during an inspection that have the potential to lead to quality issues during the manufacturing of a product. Once we observe such conditions, we can then work with a company to help identify a path forward to remedy the issues.
Indeed, it is often in the public’s best interest that the FDA work with firms to quickly resolve compliance matters to ensure that the public has access to medical products that meet the agency’s high standards for quality, safety and effectiveness.
In the case of Emergent BioSolutions, we are working with the company to address the conditions identified. At the agency’s request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues. For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we feel confident that it meets our expectations for quality.
These actions are unrelated to an ongoing evaluation by the FDA and U.S. Centers for Disease Control and Prevention of extremely rare cases of a specific type of blood clot reported in a very small number of individuals after receiving the Johnson & Johnson COVID-19 Vaccine.
We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness. We know that every time an American, including members of our own families, receives a COVID-19 vaccine dose, they are putting their trust in us. We are working hard to maintain that trust.
Additional Information:
Emergent BioSolutions 483
FDA Form 483 Frequently Asked Questions
FDA COVID-19 Vaccines
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