The Food and Drug Administration said Wednesday a facility in Baltimore that ruined millions of Johnson & Johnson Covid-19 vaccine doses was unsanitary and unsuitable for making the shots.
The FDA asked Emergent BioSolutions, which operates the facility, to temporarily suspend production of materials for Covid-19 vaccines earlier this month as the U.S. agency initiated an inspection.
“The company has not adequately trained personnel involved in manufacturing operations, quality control sampling, weighing and dispensing, and engineering operations to prevent drug cross-contamination,” FDA investigators wrote in the report.
The eight-day inspection earlier this month revealed a number of alarming quality issues throughout the facility.
In one 13 page reportInspectors wrote that the facility used to manufacture the vaccine “was not kept in a clean and hygienic condition” and was “not of the appropriate size, design and location to facilitate cleaning, maintenance and proper operation “.
FDA inspectors said paint was peeling in multiple places and walls were damaged, which could affect the facility’s “ability to adequately clean and disinfect.” They also found that when handling waste or materials used to make vaccines, employees did not follow standard operating procedures to ensure they were not contaminated.
The facility has not been approved by the FDA to manufacture or distribute Johnson & Johnson’s Covid-19 vaccine, and none of the doses manufactured at this facility have been marketed for use in the United States. Emergent has agreed to cease production of materials until the issues identified by the FDA are resolved, the agency said.
In a statement, J&J said it had “stepped up its oversight of drug manufacturing at the Emergent BioSolutions Bayview facility, including additional controls and personnel, to ensure that the quality standards of our company and the US Food & Drug Administration ( FDA) are complied with. “”
“Johnson & Johnson will exercise its regulatory authority to ensure that all FDA observations are promptly and fully considered,” it said.
Emergent said it is determined to work with the FDA and J&J to resolve the issues.
“While we are never satisfied with defects in our production facilities or processes, these can be corrected and we will take quick action to correct them,” it said in a statement.
Robert Califf, former FDA commissioner under the Obama administration, said that while the problems at the Baltimore plant appear “troubling”, manufacturing issues are emerging and one reason FDA oversight is so important.
“Supply chain and manufacturing are really complicated issues, but that’s why you need an FDA and inspections, and it’s the shared responsibility of the FDA and the companies themselves,” he told CNBC in a telephone interview.
At the beginning of this month the Biden administration appointed J&J to manage the Baltimore facility after US officials learned that Emergent, a contract manufacturer, made vaccines for J&J and J&J AstraZeneca, Ingredients mixed for the two shots. Officials also stopped production of the AstraZeneca vaccine.
The stoppage in the production of new materials is the most recent setback for J&J. Last week the FDA and the Centers for Disease Control and Prevention did advised states to stop temporarily J & J’s use of the vaccine “out of caution” after six women developed a rare but potentially life-threatening bleeding disorder in which one was dead and one in critical condition. A key CDC panel is due to meet on Friday to make a recommendation on how to use the vaccine.
The FDA said Wednesday that its actions at the Baltimore facility had nothing to do with the ongoing evaluation of the coagulation cases.