A U.S. Food and Drug Administration inspection report found unhealthy conditions and other problems at a Baltimore plant that destroyed more than 15 meters of Johnson & Johnson coronavirus vaccine doses.
The FDA reported that the facility operated by Emergent BioSolutions “is not maintained in a clean and sanitary condition.” The report says that the paint on the walls of the plant was peeling in several areas, and paint stains were found on the floor.
The report also found brown residue on the walls and floors.
In late March, the doctor said he found a problem with an ingredient used in the single-injection Covid vaccine at a production site in Baltimore, Maryland, and stopped production there. The factory belongs to Emergent Biosolutions, one of the more than 10 companies that Johnson & Johnson uses to accelerate production.
FDA officials analyzed footage from factory security cameras to make the report. Filming from January 27 to February 3 showed workers not complying with cross-contamination prevention procedures in several cases.
Product components, containers and closures have not been stored in a manner that prevents contamination, according to the FDA report.
“We will not allow the release of any product until we are confident that it meets our quality expectations,” reads an FDA statement.
“The company has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weighing and distribution and engineering operations to prevent cross-contamination,” the report said.
The report also states that the equipment in the plant was not of adequate size to facilitate operations for intended use or cleaning.
“Johnson & Johnson will exercise its oversight authority to ensure that all FDA comments are addressed promptly and comprehensively,” the statement said. “The company will also redouble its efforts as it continues to work to secure emergency use in the United States for the drug manufactured at Emergent Bayview as soon as possible so that the company can help complete this global pandemic. ”
U.S. health officials have discontinued Johnson & Johnson Covid-19 vaccine, while scientists have investigated the potential link between rare cases of blood clots and their vaccine.
On Tuesday, the European Union recommended adding a warning to information on the vaccine product and stressing that the benefits of shooting outweighed its risks.
Johnson & Johnson vaccine use is still pending in the United States, and the Centers for Disease Control and Prevention is expected to meet Friday to discuss the break.