The FDA cited a number of concerns with the Emergent BioSolutions plant where COVID-19 vaccine manufacturing has been halted in an inspection report released April 21.
During an inspection April 12-20, the FDA cited nine violations, ranging from the building being an inadequate size to the plant failing to train employees properly.
The FDA also said Emergent BioSolutions failed to properly investigate the incident that caused 15 million Johnson & Johnson COVID-19 vaccine doses to be thrown out after ingredients for it were mixed up with ingredients for AstraZeneca's vaccine.
"There is no assurance that other batches have not been subject to cross-contamination," the FDA investigators wrote in the inspection report. The agency said all vaccines made at the plant will undergo additional testing before they are allowed to be released.
"We will not allow the release of any product until we feel confident that it meets our expectations for quality," acting FDA Commissioner Janet Woodcock, MD, and Director of the Center for Biologics Evaluation and Research Peter Marks, MD, PhD, stated in a news release.
No vaccines manufactured at the plant have been distributed for use in the U.S. Production at the plant has been delayed while Emergent works with the FDA to resolve the issues.
The FDA noted that the citations have nothing to do with the ongoing investigation by the FDA and CDC into extremely rare cases of a specific type of blood clot reported in a small number of people after receiving the Johnson & Johnson COVID-19 vaccine.
Emergent BioSolutions told The New York Times April 21 that "While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable, and we will take swift action to remedy them."
Johnson & Johnson told the Times that it has already stepped up its oversight of the plant and that it would "ensure all of the FDA's observations are addressed promptly and comprehensively."
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