The US Food and Drug Administration announced on Wednesday that it recently completed an inspection of the Emergent BioSolutions facility in Baltimore – which makes the drug substance that goes into Johnson & Johnson's coronavirus vaccine. New production is still paused while FDA and Emergent work through several potential quality issues.
The FDA's inspection ended Tuesday and "cited a number of observations concerning 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 released on Wednesday.
They emphasized no products will be released before meeting the FDA’s quality standards.
The FDA report says Emergent has not thoroughly investigated cross-contamination of a viral vaccine drug substance batch, and the investigation did not include a thorough review of how people moved in and around the facility as a potential source of contamination.
“There is no assurance that other batches have not been subject to cross-contamination,” the report says.
The report also says, based on security camera footage and direct observation, written procedures to prevent cross-contamination “are not followed” during production and not documented. Components and product containers were not handled or store in a way to prevent contamination, the report says; written procedures to assure drug substances are manufactured at the appropriate quality, strength and purity “are inadequate”; and employees weren’t adequately trained.
The building used to manufacture the vaccine drug substance wasn’t a suitable size or design to facilitate cleaning and proper operations, and equipment used “is not of adequate size” to operate as intended,” the report says.
Additionally, the FDA's inspection document notes peeling paint, unsealed bags of medical waste, residue on walls and damaged floors and rough surfaces that "do not allow for adequate cleaning and sanitization.”
In a statement, Emergent said it is “committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified.”
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