The U.S. Food and Drug Administration announced Wednesday that it recently completed an inspection of the Emergent BioSolutions facility in Baltimore – which makes the drug into the Johnson & Johnson coronavirus vaccine. New production is still discontinued while the FDA and Emergent work through several potential quality issues.
The FDA inspection ended Tuesday and “cited a number of comments regarding whether the plant’s processes meet our requirements and standards,” said Dr. Janet Woodcock, FDA’s acting commissioner, and Dr. Peter Marks, director of the FDA’s Center for Evaluation and Biological Research said in a joint statement released on Wednesday.
They stressed that no products will be released until the FDA meets quality standards.
The FDA report says Emergent did not thoroughly investigate cross-contamination of a batch of viral vaccine drugs, and the investigation did not include a thorough review of how people moved in and around the facility as a possible source of contamination.
“There is no assurance that other lots have not been subjected to cross-contamination,” the report said.
The report also says that, based on security camera footage and direct observation, written procedures to prevent cross-contamination “are not followed” during production and are not documented. Product components and containers have not been handled or stored in a manner that prevents contamination, the report states; written procedures to ensure that medicinal substances are manufactured to the appropriate quality, strength and purity “are inadequate”; and employees were not adequately trained.
The building used to manufacture the vaccine drug was not the right size or design to facilitate proper cleaning and operation, and the equipment used “is not of the right size” to function as intended, the report said.
In addition, the FDA inspection document notes peeling paint, unsealed bags of 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 was “committed to working with the FDA and Johnson & Johnson to resolve the issues quickly.”