The Baltimore plant where they mixed substances and spoiled millions of J&J vaccines, presented multiple problems according to the information from an FDA inspection
Photo: PHILL MAGAKOE / AFP / Getty Images
Wednesday, November 27
What flaws the FDA found in the plant where 15 million Johnson & Johnson vaccines went bad
The problems do not stop for the Baltimore plant where they went to waste 15 million doses of the Covid vaccine – by Johnson & Johnson , as a report from the Food and Drug Administration obtained by NBC News reveals that federal inspectors detected up to 9 “observations” in the facilities .
After the inspection work, the FDA indicates that the plant operated by Emergent BioSolutions is not maintained in a clean and hygienic condition adequately decontaminate the wastes generated during the manufacture of the vaccine drug substance a, as well as peeling paint and unidentified black and brown residue on floors and walls .
According to the FDA report in the operated plant by Emergent BioSolutions, vaccine waste is transported through the warehouse prior to disposal and has the potential to contaminate the area and adjacent areas.
FDA inspectors reported in their report, known as Form 84, which Emergent BioSolutions has “ failed to adequately train personnel involved in manufacturing operations , quality control sampling, weighing and dispensing, and engineering operations to prevent cross contamination of bulk pharmaceutical substances ” .
Jan l Form 800 the FDA registered a total of nine “observations” in the facilities , which according to the agency, have the potential to generate quality problems during the manufacture of a product .
The observations reported are:
– Unsanitary conditions in the plant
– Ingredient cross contamination (not fully investigated)
– The building is not of adequate size, design and location
– Process control procedures to prevent cross contamination , are not documented
– The components of the ingredients of the vac a are not stored correctly
– Adequate training is not carried out
– The equipment is not the correct size
– The equipment is not cleaned properly
The FDA said that Emergent BioSolutions agreed to stop new production while working with the agency to solve possible quality problems .
The FDA noted that for already manufactured vaccines, the Products will undergo additional testing and thoroughly evaluated to ensure quality before any distributions potential ion, “We will not allow any product launch until meets our quality expectations “, confirmed the agency.
With information from NBC News
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