The U.S. Food and Drug Administration announced Wednesday that it recently completed an inspection of Baltimore’s Emergent BioSolutions facility, which manufactures the drug substance that enters Johnson & Johnson’s coronavirus vaccine. New production is still on hold as the FDA and Emergents work through several potential quality issues.
The FDA inspection ended Tuesday and “cited several observations on whether the facility’s processes meet our requirements and standards,” Dr. Janet Woodcock, acting commissioner of the FDA, and Dr. Peter Marks, director of the FDA’s Center for Biological Assessment and Research, said in a joint statement released Wednesday.
They stressed that no products will be released before they meet FDA quality standards.
The FDA report says Emergent has not thoroughly investigated the cross-contamination of a batch of pharmacological substances for viral vaccines and the investigation did not include a thorough review of how people moved at the facility and in the around it as a potential source of pollution.
“There is no guarantee that other batches have not been subject to cross-contamination,” the report says.
The report also says that, based on images from security cameras and direct observation, written procedures to prevent cross-contamination “are not followed” during production and are not documented. The report says the components and packaging of products were not handled or stored in a way that could prevent contamination. written procedures to ensure that pharmaceutical substances are manufactured with the appropriate quality, strength and purity “are inadequate”; and employees did not have adequate training.
The building used to make the pharmacological substance of the vaccine was not a suitable size or design to facilitate proper cleaning and operations, and the equipment used “is not the right size” to function as intended. ‘report.
In addition, the FDA inspection document notes exfoliating paint, bags of unsealed medical waste, debris on damaged walls and floors, and rough surfaces that “do not allow for proper cleaning and sanitation.”
In a statement, Emergent said it is “committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified.”