Baltimore plant with contaminated Johnson & Johnson vaccines had multiple failures
Last edited Wed Apr 21, 2021, 04:32 PM - Edit history (1)
Source: Washington Post
The Food and Drug Administration on Wednesday released a scathing inspection report that notes unsanitary conditions and other serious failures at the Emergent BioSolutions manufacturing plant in Baltimore that ruined 15 million doses worth of raw Johnson & Johnson coronavirus vaccine. The 12 pages of findings portray a plant with systemic problems, some of which echo concerns cited in a 2020 inspection report, including poor training of workers.
In the latest check, which began last week after the contamination, inspectors found that medical waste was improperly handled. Sensitive work areas had peeling paint and black and brown residue on walls. Through a review of security camera footage, the FDA documented workers repeatedly failing to follow procedures to prevent cross-contamination of various vaccines being manufactured there. The raw batches of Johnson & Johnson vaccine were ruined in March in a cross-contamination incident that involved ingredients from AstraZeneca’s coronavirus vaccine.
The episode has disrupted Johnson & Johnson’s manufacturing plan for the United States, as well as AstraZeneca’s. Both vaccines use a harmless virus to trigger coronavirus immunity in the human body after being injected. The live virus can spread during manufacturing, and careful handling is required. Emergent, a contract manufacturer, is so far Johnson & Johnson’s only U.S. production facility for raw vaccine substance. But it has not been certified to manufacture the vaccine by the FDA. No vaccine made there is permitted to be used for shots in patients, and vaccine that has already been put into vials and prepared for shipment is under quarantine.
“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” the FDA said in a news release Wednesday. Vaccine manufacturing plants must be vigilant about the potential for cross-contamination, specialists said. “Cross-contamination is serious since if undetected, it could lead to significant adverse medical events,” said Peter D. Smith, a former FDA investigator and manufacturing inspections official who is a consultant at Smith GMP Consulting in Rhode Island. He reviewed the FDA inspection report at the request of The Washington Post.
Read more: https://www.washingtonpost.com/business/2021/04/21/fda-johnson-johnson-vaccine-inspection/
Full headline: Baltimore plant with contaminated Johnson & Johnson vaccines had multiple failures, unsanitary conditions, FDA says
Original article -
The report says Emergent has identified a batch of media used to manufacture Johnson & Johnson vaccine as the most likely cause of the cross-contamination. But the report cites a ``failure to conduct thorough investigations into unexplained discrepancies.'' It also cites a number of unsanitary conditions at the plant. It said waste was not decontaminated and that inspectors found peeling plant in sensitive manufacturing areas.
In another finding, the report said a review of security camera footage showed employees failing to follow proper procedures in the handling of medical waste. Emergent said it was working to correct problems identified in the inspection report. ``While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them,'' the company said.
It called its employees, who are cited multiple times in the FDA report for not following procedures to prevent cross-contamination of vaccines, ``a heroic workforce who have stepped up to work 24/7 to ensure vaccines will be produced with the highest quality and quickly available to fight this pandemic.''
Must have released the 483. This is the type of stuff that happens with inspections of some of the more schlock places.
= new reply since forum marked as read
By Christopher Rowland
April 21, 2021 at 1:45 p.m. EDT
The Food and Drug Administration on Wednesday released a scathing inspection report that notes unsanitary conditions and other serious failures at the Emergent BioSolutions manufacturing plant in Baltimore that ruined 15 million doses worth of raw Johnson & Johnson coronavirus vaccine. The 12 pages of findings portray a plant with systemic problems, some of which echo concerns cited in a 2020 inspection report, including poor training of workers.
In the latest check, which began last week after the contamination, inspectors found that medical waste was improperly handled. Sensitive work areas had peeling paint and black and brown residue on walls. Through a review of security camera footage, the FDA documented workers repeatedly failing to follow procedures to prevent cross-contamination of various vaccines being manufactured there. The raw batches of Johnson & Johnson vaccine were ruined in March in a cross-contamination incident that involved ingredients from AstraZeneca’s coronavirus vaccine.
The episode has disrupted Johnson & Johnson’s manufacturing plan for the United States, as well as AstraZeneca’s. Both vaccines use a harmless virus to trigger coronavirus immunity in the human body after being injected. The live virus can spread during manufacturing, and careful handling is required. Emergent, a contract manufacturer, is so far Johnson & Johnson’s only U.S. production facility for raw vaccine substance. But it has not been certified to manufacture the vaccine by the FDA. No vaccine made there is permitted to be used for shots in patients, and vaccine that has already been put into vials and prepared for shipment is under quarantine.
“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” the FDA said in a news release Wednesday. Vaccine manufacturing plants must be vigilant about the potential for cross-contamination, specialists said. “Cross-contamination is serious since if undetected, it could lead to significant adverse medical events,” said Peter D. Smith, a former FDA investigator and manufacturing inspections official who is a consultant at Smith GMP Consulting in Rhode Island. He reviewed the FDA inspection report at the request of The Washington Post.
https://www.washingtonpost.com/business/2021/04/21/fda-johnson-johnson-vaccine-inspection/
