Silver Spring, MD – The U.S. Food and Drug Administration (FDA) have announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
As part of the agency’s 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.
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 the inspection, the FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards.
These observations are outlined in the 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.
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.
The FDA’s Center for Food Safety and Applied Nutrition updated its COVID-19 Vaccination & Food and Agriculture Sector webpage to include the HHS COVID-19 Vaccination Toolkit for agriculture workers.
Testing updates:
As of today, 369 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 270 molecular tests and sample collection devices, 76 antibody and other immune response tests, and 23 antigen tests. There are 49 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four over-the-counter (OTC) at-home antigen tests, and two OTC molecular tests.
The FDA has authorized 8 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 466 revisions to EUA authorizations.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
