Other safety alerts
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| The United States: FDA continues important steps to ensure quality, safety and effectiveness of authorized COVID-19 vaccines |
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The US Food and Drug Administration (FDA) announces that it 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 United States.
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, the FDA cited a number of observations concerning whether the facility’s processes met FDA’s requirements and standards. These observations are outlined in FDA’s inspection closeout report, also known as a “FDA Form 483.”
In the case of Emergent BioSolutions, FDA is 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. FDA will not allow the release of any product until it feels confident that it meets FDA’s expectations for quality.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-continues-important-steps-ensure-quality-safety-and-effectiveness-authorized-covid-19-vaccines
In Hong Kong, the above product is not a registered pharmaceutical product. There is also no registered pharmaceutical product manufactured by Emergent BioSolutions.
Ends/Thursday, Apr 22, 2021
Issued at HKT 15:00
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