FDA reports peeling paint, other issues at J&J vaccine plant

The U.S. Food and Drug Administration in a 12-page report listed a number of problems found at a Baltimore, Maryland plant that makes Johnson & Johnson’s COVID-19 vaccine - including peeling paint, poor sanitation and brown and black substances on surfaces - forcing a pause in manufacturing.

Emergent Biosolutions, which owns the plant, has been seeking regulatory authorization to make the J&J vaccine there, but stopped production recently after being asked to do so by the FDA.

The FDA detailed a long list of problems to fix, including failure to train personnel to avoid cross contamination of COVID-19 vaccines from Johnson & Johnson and AstraZeneca, which had also been produced at the site.

Production of the AstraZeneca vaccine, which is not yet authorized for use in the United States, was previously stopped at the Emergent plant after ingredients from that shot contaminated a batch of J&J vaccine, ruining millions of doses.

The FDA inspection, which was carried out between April 12 and April 20, found the building was not of the suitable size or design to facilitate cleaning, maintenance or proper operations.

The report cited security camera footage of production staff carrying unsealed bags of medical waste around the facility, bringing it into contact with containers of material used in manufacturing.

J&J said it will exercise its oversight authority to ensure that all of the observations from the regulator are addressed promptly and comprehensively.

The healthcare company said it was redoubling its efforts to get authorization for the facility as quickly as possible, but did not provide a timeline for when it could resume operations.

No vaccine manufactured at this plant has been distributed for use in the United States.