The U.S. Food and Drug Administration (FDA) on Wednesday (21) in a report criticized a new crown vaccine factory in Maryland for too many problems, such as peeling paint, cracks in the barrels of raw materials, poor sanitation, and inadequate employee training. The plant has been ordered to shut down production and will take at least several months of consolidation before production can resume.
The plant, located in Baltimore, is part of an emerging biotech company that originally produced two vaccines at the same time: one developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and the other jointly developed by Astellicom (AZ) Pharmaceuticals and Oxford University. A few weeks ago, plant employees mistakenly mixed up the ingredients of the two vaccines, leading to the scrapping of as many as 15 million doses of Johnson & Johnson’s vaccine.
The FDA asked the plant to shut down earlier this month and inspected the plant from April 12 to 20, including viewing surveillance video and sending people to inspect the site. 21 they released a more than 10-page investigation report, exposing many safety concerns and health problems in the plant.
The U.S. report said that the factory space is narrow, employees walking inevitably bumped into the barrels of raw materials; the walls are badly painted, paint spots can be seen everywhere on the floor, and even the workshop where drugs are bottled after being made is no exception. For example, there were brown stains on the walls and black stains on the floor of one of the workshops. Employees walked around with unsealed medical waste and often bumped into containers containing vaccine ingredients; some of the ingredient drums were cracked.
The cleaning process was also “sloppy” and often just a formality. For example, some employees went to and from the different ingredient rooms without documenting whether they changed their protective clothing and showers as required, and others left their protective clothing on the floor and later threw it into the trash cans with the lids up all the time.
The report said the plant had previously confused Johnson & Johnson vaccine with Astellicam vaccine ingredients, and now an on-site investigation found that “it is difficult to ensure that other batches of vaccines are not similarly cross-contaminated.
All of the Johnson & Johnson vaccines currently in use are produced in the Netherlands. Johnson & Johnson had planned to switch to supplying New Crown vaccine from its Maryland plant from April, but the mix-up disrupted the plan.
“Reuters quoted the U.S. think tank “Center for Global Development” health care supply chain issues expert Yadav, reported that the factory exploded part of the problem “quite serious”, a complete The complete overhaul “could take months”.
In response to the latest investigation report, Johnson & Johnson pledged to take immediate steps to eliminate the potential problems. The emerging biotechnology company issued a statement, promising to cooperate with the U.S. Drug Enforcement Administration and Johnson & Johnson to rectify the problems mentioned in the report.
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