Company at heart of Johnson & Johnson's vaccine woes has series of citations

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The company at the center of problems that led Johnson & Johnson to discard a COVID-19 vaccine batch has been cited before for quality-control issues.

The company at the center of quality problems that led Johnson & Johnson to discard an unknown amount of its COVID-19 vaccine has a string of citations from U.S. health officials for quality-control problems.

Emergent BioSolutions, a little-known company at the center of the vaccine supply chain, was a key to Johnson & Johnson’s plan toto the U.S. by the end of May. But the company has been cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold at one of its facilities, according to records obtained by the Associated Press through the Freedom of Information Act.

The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with Johnson & Johnson was being announced. The agency criticized the company for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP. The FDA’s lead investigator cited the company for failing to train employees “in the particular operations they perform as part of their function and current good manufacturing practices.

 

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emergentbiosolu became very prosperous being the sole supplier of the Anthrax vaccine for the DoD. There are also connections with the ChertoffGroup. Yes, that Chertoff.

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