The U.S. Food and Drug Administration announced on Wednesday that it recently completed an inspection of the Emergent BioSolutions facility in Baltimore – which makes the medicinal compound that goes into Johnson & Johnson’s coronavirus vaccine. New production continues to be paused while FDA and Emergent resolve several potential quality issues.
The FDA inspection ended Tuesday, citing a number of observations as to whether the facility’s processes met our requirements and standards, 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 Wednesday.
They stressed that no products will be released until they meet FDA quality standards.
The FDA report says Emergent did not thoroughly investigate the cross-contamination of a batch of viral vaccines with drugs, and the investigation did not include a thorough investigation of how people move around the facility as a potential source of contamination.
“There is no guarantee that other batches have not been subject to cross-contamination,” the report said.
The report also says that, based on CCTV footage and direct observation, written procedures to prevent cross-contamination “are not followed” during production and are not documented. Components and product containers were not handled or stored in a way to prevent contamination, the report said; written procedures to ensure that drug substances are manufactured of the correct quality, strength and purity “are inadequate”; and employees were not sufficiently trained.
The building used to manufacture the vaccine substance was not of an appropriate size or design to facilitate cleaning and correct operations, and the equipment used “is not of a sufficient size” to function as intended, “the report said.
In addition, the FDA’s inspection document lists peeling paint, unsealed bags of medical waste, residue on walls and damaged floors, and rough surfaces that “do not allow for adequate cleaning and disinfection.”
In a statement, Emergent said it is “committed to working with the FDA and Johnson & Johnson to quickly resolve the identified issues.”