FDA Issues 9 Citations to Plant Making Johnson & Johnson COVID Vaccine
Summary by Cindy Olmstead
The FDA slapped the Baltimore Emergent BioSolutions facility with nine citations after investigating an incident where 15 million doses of Johnson & Johnson’s vaccine had to be discarded because they were contaminated with AstraZeneca’s vaccine ingredients.
The citations ranged from problems with sanitation and cleanliness issues with the building to lack of control procedures to prevent cross contamination of products. One note also said that employees were seen on security footage failing to follow proper procedures for handling non-disinfected and non-decontaminated medical waste.
Employees also were observed throwing unsealed waste across a floor in a warehouse. Other contamination prevention procedures also were ignored, the citations said, and the FDA saw “no assurance that other batches have not been subject to cross contamination.” As per the 15 million wasted vaccine doses, the FDA said Emergent had “failed to properly investigate the incident.”
“The FDA noted that the citations have nothing to do with the ongoing investigation by the FDA and CDC into extremely rare cases of a specific type of blood clot reported in a small number of people after receiving the Johnson & Johnson COVID-19 vaccine,” according to Becker’s Hospital Review.
SOURCES:
Becker’s Hospital Review April 21, 2021