FDA Cites Disinfection Issues at Proposed Vaccine Production Site

Following an inspection of Emergent BioSolutions, a Baltimore, MD-based manufacturing facility tapped to produce the Johnson & Johnson COVID-19 vaccine, FDA says it found a number of observations concerning whether the facility’s processes meet the agency’s requirements and standards. Among the issues noted were improper disinfection.   
 
The observations were outlined in FDA’s inspection closeout report, also known as a FDA Form 483. 

The FDA said the 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. 
 
In a statement released today, FDA said it is working with Emergent BioSolutions to address the conditions identified, which also included cross contamination in addition to sanitation.
 
At the agency’s request, Emergent BioSolutions has agreed to pause new production while it works with 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, said FDA, noting that it will not allow the release of any product until it feels confident that it meets expectations for quality. 
 
The FDA said it has not authorized the 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 US, the agency said in a statement from Janet Woodcock M.D., acting commissioner.
 
Johnson & Johnson had announced on March 31 that its “quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.”