Summary by Cindy Olmstead<\/p>\n
The FDA slapped the Baltimore Emergent BioSolutions facility with nine citations after investigating an incident where 15 million doses of Johnson & Johnson\u2019s vaccine had to be discarded because they were contaminated with AstraZeneca\u2019s vaccine ingredients.<\/p>\n
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.<\/p>\n
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 \u201cno assurance that other batches have not been subject to cross contamination.\u201d As per the 15 million wasted vaccine doses, the FDA said Emergent had \u201cfailed to properly investigate the incident.\u201d<\/p>\n
\u201cThe 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,\u201d according to Becker\u2019s Hospital Review.<\/p>\n
SOURCES:<\/p>\n
Becker\u2019s Hospital Review April 21, 2021<\/a><\/p>\n FDA Inspection Report April 12-20, 2021<\/a><\/p>\n