Scathing FDA report finds J&J Covid vaccine plant where 15mn doses were ruined is unsanitary, staff training inadequate
US health inspectors have ordered a Baltimore plant that was manufacturing Johnson & Johnson's Covid-19 vaccine to rectify a series of issues that could potentially contaminate the jab and seriously jeopardize its safety.
The 12-page report by the Food and Drug Administration (FDA) laid bare a litany of health and safety issues at the Maryland factory, where production of J&J's Janssen jab was halted last month after 15 million doses were spoiled.
The alarming details, published on Wednesday, are the result of an FDA probe conducted between April 12 and April 20 at the plant owned by Emergent Biosolutions Inc.
After reviewing CCTV footage and visiting the site in person, inspectors made a number of observations, including that the building housing the production line was not kept in a clean condition, and staff were not properly trained to prevent cross-contamination.
Peeling paint on the walls and floors was spotted, which inspectors said “impacts the firm's ability to adequately clean and disinfect the area.”
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Employees in one manufacturing area were seen throwing unsealed bags of medical waste into an elevator and removing their protective clothing near raw materials.
Personal hygiene was also flagged as a problem, with one member of staff who moved between different manufacturing zones only recorded once in the plant's shower logbook.
Other issues cited included staff not cleaning equipment properly and the “failure to conduct thorough investigations” related to a leak as a batch was filled.
The FDA has informed Emergent Biosolutions Inc. of the issues and the company is now required to respond.
The concerns raised in the report may take months to resolve, according to experts cited by Reuters. The FDA and J&J have not released a date for production to restart.
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In a statement on Wednesday, J&J pledged to ensure that the FDA's observations at the plant are addressed “promptly and comprehensively.”
The company added that it would bolster global production capacity by enlisting 10 manufacturing sites across different countries in addition to its own plant in Leiden, the Netherlands.
The FDA said its investigation into the Baltimore plant is unrelated to an ongoing review of extremely rare cases of blood clotting in people who have received the Janssen vaccine.
Last week the regulator recommended a pause in the jab's US rollout to allow its investigation of clots to take place.
A review of the US clotting cases carried out by the European Medicine Agency found a possible link between the condition and the inoculation, but said the benefits of the vaccine outweigh its risks.
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