WASHINGTON - The U.S. Food and Drug Administration cited multiple inspection failures at a Baltimore plant that is a proposed manufacturing facility for the Johnson & Johnson COVID-19 vaccine, according to a report issued Wednesday.
During the inspection, the FDA cited a number of observations at Emergent BioSolutions concerning whether the facility’s processes met the administration’s requirements and standards. Emergent BioSolutions has agreed to pause new production while it works to resolve the issues.
The report found the plant, which previously was revealed to have ruined up to 15 million doses of the vaccine, was "not maintained in a clean and sanitary condition," and procedures to prevent cross-contamination were "not followed in the execution of production."
"The firm has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross-contamination of bulk drug substances," the inspection report continued.
The 13-page document also noted that equipment was "not cleaned or maintained at appropriate intervals" and was "not of adequate size to facilitate operations for its intended use."
"At the agency’s request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues," the FDA said Wednesday. "We will not allow the release of any product until we feel confident that it meets our expectations for quality."
The FDA has not yet authorized this facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S., according to Johnson & Johnson.
"This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process," Johnson & Johnson’s statement said on March 31.
The FDA’s inspection report comes just a few days after top House Democrats launched an investigation into whether Emergent Biosolutions leveraged its relationship with a key Trump administration official to profit from federal contracts despite a track record of raising prices and failing to meet contract requirements, and whether these actions impeded the nation’s response to the coronavirus crisis.
"Specifically, we are investigating reports that Emergent received multi-million-dollar contracts to manufacture coronavirus vaccines despite a long, documented history of inadequately trained staff and quality control issues," Rep. Carolyn B. Maloney, Chairwoman of the House Committee on Oversight and Reform, and Rep. James E. Clyburn, Chairman of the Select Subcommittee on the Coronavirus Crisis, wrote in a press release.
Meanwhile, the FDA said on Wednesday it is "doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness. We know that every time an American, including members of our own families, receives a COVID-19 vaccine dose, they are putting their trust in us. We are working hard to maintain that trust."
This inspection of the plant also follows an ongoing evaluation by the FDA and the U.S. Centers for Disease Control and Prevention of extremely rare cases of a specific type of blood clot reported in a very small number of individuals after receiving the Johnson & Johnson COVID-19 vaccine.
U.S. regulators recommended a "pause" on the vaccine while the investigation continues.
This story was reported from Los Angeles.