Violations of a US medical facility manufacturing Johnson & Johnson vaccine

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The report of the inspectors said Food and Drug Administration At 13 pages, the plant operated by Emergent Bio Solutions is not maintained “to keep it in a clean and hygienic condition.”

Inspectors found peeling paint and unidentified black and brown residues on floors and walls, in addition to failure to purify the waste generated during vaccine manufacturing. “This waste is transported through warehouses before disposal, and it can contaminate the warehouse and surrounding areas,” according to the report.

The inspectors added that the company “has failed to train personnel involved in manufacturing operations, and to take quality control samples, weighing, distribution and engineering operations, to prevent Contamination of pharmaceutical materials“.

The inspection, which was completed on Tuesday, came after facility workers mixed components of the J&J vaccine with vaccine ingredients.AstraZenecaDuring an incident that occurred at the end of last March.

The mixing did not affect any of the Johnson & Johnson doses that were administered in the United States, as they were made in Holland, But it delayed future shipments.

A report was made US Food and Drug Administration Nine “notes” about the facility, the agency said, likely to cause “quality issues during product manufacture.”

The observations included the failure to complete a “comprehensive examination of the contamination of components”, the failure to store the vaccine components properly, in addition to the fact that the building does not meet the appropriate standards in terms of “size, design and location”, along with notes on the cleanliness of the equipment and its measurements.

The Food and Drug Administration announced that the company, “Emergent Bio-Solutions,” agreed to stop the new production temporarily, “to solve potential quality problems,” and confirmed that the vaccines manufactured in the facility “will undergo additional tests and will be carefully evaluated to ensure their quality before any possible distribution.

A spokesman for “Emergent Bio-Solutions” said that the US Food and Drug Administration’s comments would help the company “continue to improve and enhance the supply chain for Johnson & Johnson vaccine,” pledging to take “rapid action to address it.”

a company “Johnson & Johnson“She, in turn, confirmed in a statement that she would work to ensure that” all observations of the Food and Drug Administration are promptly and comprehensively addressed. “

The Food and Drug Administration indicated that its procedures are not related to the continuous evaluation of the “Johnson & Johnson” vaccine regarding “extremely rare” cases of a certain type of blood clots reported in some of the vaccine recipients.

And the US health authorities recommended last week to stop giving the vaccine, until the end of the investigation into reports of blood clots.





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