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Johnson & Johnson Factory has Problems, says FDA Inspection

Johnson & Johnson had hired the Baltimore Factory to help them in making the Covid-19 vaccine and it was found dirty. It did not follow the proper manufacturing process and also had poorly trained staff. These practices resulted in contamination of material going into the batch of shots. A detailed statement of the findings has been released by the Food and Drug Administration.

According to agency inspectors, a batch of bulk drug substance for the single-dose vaccine by Johnson & Johnson was contaminated with the material used for making Covid-19 vaccines for another Emergent client, AstraZeneca. Reportedly, the batch was enough for making almost 15 million Johnson & Johnson vaccine doses but it had to be thrown out.

Some of the other problems cited in the inspection report were peeling paint, black and brown residue on Factory walls and floors, employees not following procedures, and inadequate cleaning. No measures were found to be taken for preventing contamination between vaccine batches and ingredients.

The FDA noted that nothing made at the Factory for has been distributed. Nearly 8 million doses of vaccine administered in the US came from Europe. On Wednesday, Emergent and Johnson & Johnson said that they are working to fix the problems as soon as possible. After the problems surfaced late last month, the company took control of the Factory.

AstraZeneca vaccine manufacturing work has been moved to another Factory by the Biden Administration. AstraZeneca still needs to get emergency authorization for use in the United States. Late last week, all the Baltimore factory production was halted at the FDA’s request.

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