FDA: Issues Identified at Proposed Manufacturing Facility for Janssen COVID-19 Vaccine

In an effort to ensure the safety and quality of authorized COVID-19 vaccines, the Food and Drug Administration (FDA) recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Janssen COVID-19 vaccine.

Following the inspection, the FDA noted several potential quality and safety issues at the Baltimore-Bayview facility. These included:

• A failure to conduct thorough investigations into unexplained discrepancies related to the cross-contamination of the client viral vaccine drug substance batch with the virus from client.
• The building used for manufacture is not maintained in a clean and sanitary condition; and is not of suitable size, design, and location to facilitate cleaning, maintenance, and proper operations.
• The components, product containers and/or closures were not handled and/or stored in a manner to prevent contamination.
• Inadequate written procedures to assure that the drug substances have the correct identity, strength, quality and purity.
• Inadequate training of employees, and inadequate equipment used to facilitate operations for its intended use.

The FDA has not yet authorized Emergent BioSolutions to manufacture or distribute any Janssen COVID-19 vaccine or its components. The facility has agreed to pause new vaccine production to resolve potential quality issues, and any vaccines that were already manufactured will undergo further testing. To date, there have been no COVID-19 vaccines manufactured or distributed for use at this facility in the US. 

In a press release, Emergent BioSolutions stated: “The issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations. While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.”

References

1. FDA continues important steps to ensure quality, safety and effectiveness of authorized COVID-19 vaccines. [press release]. Silver Spring, MD; April 21, 2021. 
2. Statement on issuance of form FDA 483 at Emergent Bayview facility. [press release]. Gaithersburg, MD: Emergent BioSolutions; April 21, 2021.