A contract plant that was producing materials for Johnson & Johnson’s (J&J) CCP virus vaccines failed to meet sanitary standards, according to federal health authorities.
The U.S. Food and Drug Administration (FDA) conducted an examination of the Emergent BioSolutions manufacturing facility after production was put on pause last Friday, according to an SEC filing.
The FDA ordered Emergent BioSolutions to pause vaccine production while they work together to address “potential quality issues.”
“The FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards,” the FDA wrote in a statement.
The observations (pdf) include “cross-contamination” of vaccine substance, and found the building used for production was “not maintained in a clean and sanitary condition” and not suitable to “facilitate cleaning, maintenance, and proper operations.”
The FDA hasn’t authorized the manufacture or distribution of J&J vaccine components at the facility and none of the CCP (Chinese Communist Party) virus vaccines produced there have been distributed in the United States so far.
The FDA will test and evaluate them before potential distribution.
