A new Food and Drug Administration (FDA) report released Wednesday revealed that the Emergent BioSolutions plant used to produce Johnson & Johnson COVID-19 vaccines in Baltimore failed to follow proper safety and sanitary protocols.
The plant in question came under scrutiny in March after a cross-contamination between Johnson & Johnson and AstraZeneca ingredients spoiled around 15 million doses of the Johnson & Johnson vaccine. The mix-up was reportedly the result of human error, and now more details have come to light about the factory’s failings.
FDA inspectors said the plant was not suitable to produce vaccine doses due to a number of problems, including a lack of proper training for employees and a failure to properly review what went wrong in the contamination incident. The plant was never fully approved for vaccine manufacturing by the FDA, and none of the doses produced there were distributed to the public.
The report declared that the building used for vaccine production was not “maintained in a clean and sanitary condition.” Damaged floors and peeling paint on surfaces reportedly made it impossible for the facility to be properly cleaned. (RELATED: White House ‘Assured’ Vaccine Supply Won’t Be Interrupted By Johnson & Johnson Factory Debacle)
Furthermore, the building in question was found to not be “of suitable size, design, and location to facilitate cleaning, maintenance, and proper operations.” Employees of the plant were not “trained in the particular operation that they performed” and equipment was not cleaned in a way that could ensure the safety of the vaccines being produced, the report found.
Production at Emergent BioSolutions facility in Baltimore will remain on hold, U.S. regulators say. The facility is expected to produce J&J Covid-19 vaccinations https://t.co/UBEYV4S5RH
— Bloomberg (@business) April 21, 2021
Of the 272 million vaccine doses distributed in the U.S., only around 18 million have been from Johnson & Johnson, according to the Centers for Disease Control and Prevention. Johnson & Johnson was put in direct control of the plant by the Biden administration after the cross-contamination mistake, and the company says it is increasing oversight to ensure that everything is up to FDA standards. (RELATED: Poll: Americans No Longer Confident In Johnson & Johnson Vaccine After CDC Pause)
The FDA said it’s investigation into the Baltimore plant is not related to the recent pause in use of the vaccine over a potential connection to blood clots, according to CNBC.