The U.S. Food and Drug Administration announced on Wednesday that it recently completed an inspection of the Emergent BioSolutions facility in Baltimore, which produces the drug substance contained in Johnson & Johnson’s coronavirus vaccine. New production is still paused while FDA and Emergent resolve several potential quality issues.
The FDA’s inspection ended Tuesday and “cited a number of observations as to whether the facility’s processes were meeting our requirements and standards,” Dr. Janet Woodcock, Acting FDA Commissioner, and Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research. said in a joint statement released on Wednesday.
They stressed that no products will be released before the FDA quality standards are met.
According to the FDA report, Emergent did not thoroughly investigate the cross-contamination of a batch of viral vaccine substances, and the investigation did not include a thorough examination of how people moved in and around the facility as a potential source of contamination.
“There is no guarantee that other batches have not been exposed to cross-contamination,” the report said.
The report also states that based on surveillance cameras and face-to-face observation, written procedures to prevent cross-contamination during production are “not followed” and are not documented. Components and product containers have not been handled or stored in such a way to prevent contamination, the report said. written procedures to ensure that drug substances are manufactured in the appropriate quality, strength and purity, “are inadequate”; and the staff were not adequately trained.
The building where the vaccine substance was manufactured was not of a suitable size or construction to facilitate cleaning and proper operation, and the equipment used is “not large enough” to function as intended, “the report said .
In addition, the FDA inspection document notes peeling paint, unsealed bags of medical waste, residue on walls and damaged floors, and rough surfaces that “do not allow adequate cleaning and disinfection”.
In a statement, Emergent said it was “committed to working with the FDA and Johnson & Johnson to resolve the issues identified quickly.”
Read Also :