In a swift fall from vaccine manufacturing grace, Emergent BioSolutions has received a stinging Form 483 from the FDA that could halt production for months.
Just one day after the FDA completed an inspection of Emergent BioSolution’s Bayview plant in Maryland, the agency issued a partially redacted 12-page list of quality observations that the facility, which is now being overseen by J&J, will have to address.
Some of the issues raised by the agency will be fairly easy to fix, including “paint flecks” on the walls, “black residue” on the floors and cracked material bucket containers.
Some of the other problems outlined in the Form 483 could take longer to resolve. For example, the agency cited evidence obtained by security camera footage showing that “employees were not trained in the particular operation that they performed and/or in cGMPs related to their job function.” The infractions included improper de-gowning procedures and materials handling issues.
Even more challenging, the FDA said that Emergent’s building design, size and location are not suitable to “facilitate cleaning, maintenance and proper operations.” Under that observation, the FDA noted that a warehouse was overcrowded with materials, an area was “congested with carts” and that doors into an area are “too small as operators are unable to use a pallet jack” for moving materials in large containers.
The agency also pointed out that a cross-contamination issue has not been properly investigated. Earlier this month, Emergent was asked to pause manufacturing of J&J’s vaccine after a batch of 15 million doses was contaminated. A report from The New York Times suggested that ingredients were conflated between AstraZeneca’s and J&J’s vaccines.
A global health care supply chain expert told Reuters this week that it could now take months for Emergent to address the issues and get production back online.
Meanwhile, J&J has been stitching together a network of other manufacturing sites for its vaccine. The company is already producing vaccines at sites in the Netherlands and India, and has also struck a manufacturing deal with Merck.
Although the use of J&J’s vaccine has been temporarily halted while regulators investigate a possible link to rare blood clots, the company had been relying on Emergent to meet its goal of distributing millions more doses in the U.S. So far, none of the doses administered in the U.S. have come from Emergent’s plant.