The U.S. Food and Drug Administration announced Wednesday that it has recently completed an inspection of the Emergent BioSolutions facility in Baltimore, which manufactures the drug in Johnson & Johnson’s coronavirus vaccine. New production is still being interrupted while FDA and Emergent work through several potential quality issues.
The inspection of the FDA was terminated on Tuesday and quoted a number of comments on whether the processes of the facility meet our requirements and standards, ‘said Dr. Janet Woodcock, acting FDA commissioner, and dr. Peter Marks, director of the FDA’s center for biological evaluation and research, said in a joint statement released on Wednesday.
They stressed that no products will be released until they meet FDA quality standards.
According to the FDA report, Emergent did not conduct a thorough investigation into cross-contamination of a group of viral vaccines, and the investigation did not include a thorough review of how people moved in and around the facility as a possible source of infection.
“There is no assurance that other groups have not been subjected to cross-contamination,” the report said.
The report also states that, based on security camera 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 any way to prevent contamination, the report states; written procedures to ensure that drugs are manufactured at the appropriate quality, strength and purity “are inadequate”; and employees were not adequately trained.
The building used to manufacture the drug against vaccines was not suitable for cleaning and proper use, and the equipment used is ‘not sufficient’ to function as intended, “the report said.
In addition, the FDA’s inspection document notes that paint, unsealed bags of medical waste, residues 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.”