FDA inspectors find peeling walls and residue at US plant that ruined 15m Johnson & Johnson vaccine doses
Unsanitary conditions and other problems at a manufacturing plant were what ruined over 15m doses of Johnson & Johnson coronavirus vaccine, according to an inspection report by US Food and Drug Administration.
The FDA report published on Wednesday shows the Baltimore factory operated by Emergent BioSolutions “is not maintained in a clean and sanitary condition.”
The agency reported that proper manufacturing procedures were not followed and there were peeling paint, black and brown residue on floors and walls in the factory.
Poorly maintained facilities and a lack of employee training were other issues cited in the report, resulting in contamination of material that was going to be put in the shots.
As a result, new production was halted at the FDA's request, Dr. Janet Woodcock, acting FDA commissioner, and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a joint statement released on Wednesday.
"For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution," Woodcock and Marks said. "We will not allow the release of any product until we feel confident that it meets our expectations for quality."
“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.”
The report also shows that the equipment in the factory was not of adequate size to facilitate operations for its intended use or for cleaning.
The plant had been making coronavirus vaccines under contract for both Johnson & Johnson and AstraZeneca.
In March, a batch of Johnson & Johnson "drug product," which could have made 15 million doses of the vaccine, failed quality control and was taken out of production.
US health officials have paused distribution of the Johnson & Johnson Covid-19 vaccine as scientists probed the potential link between rare cases of blood clots and their vaccine.
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