By Carl O’Donnell and Manas Mishra
(Reuters) – A plant that makes Johnson & Johnson’s COVID-19 vaccine has to solve a long list of problems, including paint peeling, poor sanitation, and brown and black substances on surfaces, the U.S. Food and Drug Administration said. a 12-page report about the facility, which has paused production.
Emergent Biosolutions, owner of the factory, has requested regulatory approval to make the J&J vaccine there. It recently stopped production at the plant and said the FDA had asked it to do so after an inspection.
Johnson & Johnson reiterated on Wednesday that it was in the process of establishing a global supply chain that would involve 10 manufacturing sites in the production of the COVID-19 vaccine, in addition to the factory in Leiden, the Netherlands.
The FDA said its inspections were complete and the agency released a report with a long list of issues to be addressed, including failure to train personnel to avoid cross-contamination from Johnson & Johnson and AstraZeneca COVID-19 vaccines, which were also produced on the website.
Emergent was not immediately available for comment.
Production of the AstraZeneca vaccine, which has not yet been approved for use in the United States, was previously halted at the Emergent plant after ingredients from that shot contaminated a batch of J&J vaccine, ruining millions of doses.
The FDA also noted that Emergent did not produce adequate reports showing that the vaccine it produced met quality standards.
The inspection, which was conducted between April 12 and April 20, revealed that the building was not the correct size or design to facilitate cleaning, maintenance or proper operations.
It described a wall with a brown substance on it. The FDA also said the equipment used was not large enough for proper cleaning and maintenance.
The FDA report cited security camera footage of production workers carrying unsealed bags of medical waste around the facility and bringing it into contact with containers of material used in its production.
Workers also failed to consistently record the required showering and removal of coats when entering and exiting the sterile production area.
J&J said it will exercise its supervisory authority to ensure that all comments from the regulator are dealt with promptly and completely.
The health care company said it redoubled its efforts to get approval for the facility as soon as possible, but did not provide a timeline for when it could resume operations.
No vaccine manufactured in this facility has been distributed for use in the United States.
(Reporting by Manas Mishra and Ankur Banerjee in Bengaluru; Carl O’Donnell in New Yor; edited by Caroline Humer, Peter Henderson and Bill Berkrot)