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The Food and Drug Administration is investigating what caused a batch of the active ingredient for Johnson & Johnson’s Covid-19 vaccine to be scrapped for failing to meet quality standards at a contract manufacturing plant, according to a person familiar with the matter. The FDA may send an inspection team to assess the situation at the Baltimore plant operated by contractor Emergent BioSolutions Inc., the person said. The regulatory scrutiny follows J&J’s disclosure Wednesday that a batch of the main ingredient for its Covid-19 vaccine manufactured at the Emergent plant didn’t meet standards. The batch didn’t reach the vial-filling and finishing stage, and no doses from it were distributed. (Loftus and Burton, 4/1)

The company at the center of quality problems that led Johnson & Johnson to discard 15 million doses of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems.Emergent BioSolutions, a little-known company vital to the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its single-shot vaccine to the United States by the end of May. But the Food and Drug Administration repeatedly has cited Emergent for problems such as poorly trained employees, cracked vials and problems managing mold and other contamination around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017. (Lardner, Dearen and Johnson, 4/1)

In April last year, an investigator from the Food and Drug Administration reported problems he had discovered at a Baltimore plant operated by Emergent BioSolutions, a major supplier of vaccines to the federal government. Some employees had not been properly trained. Records were not adequately secured. Established testing procedures were not being followed. And a measure intended to “prevent contamination or mix-ups” was found to be deficient. (Swaine and Rowland, 4/2)

In a stern letter, the U.S. Office of Special Counsel rebuked the Food and Drug Administration over four instances in which agency officials belatedly downgraded troubling findings at manufacturing plants and also urged the FDA to rethink its approach to oversight of inspections. The investigating agency cited, in particular, a high-profile episode involving a Merck (MRK) vaccine plant in North Carolina, where a whistleblower tipped off the FDA to numerous sanitary problems. An FDA inspector who subsequently visited the plant maintained the violations were serious enough to warrant action by both the FDA and the drug maker. But his recommendations were minimized by supervisors. (Silverman, 4/1)

A contractor Johnson & Johnson enlisted to make its coronavirus vaccine acknowledged Thursday that it had contaminated millions of doses, confirming reports of supply problems related to the firm's Maryland facility. The acknowledgment by Emergent BioSolutions came one day after news reports revealed the mistake at its West Baltimore plant that affected 15 million doses. The company signed on to produce a J&J vaccine substance last spring and later added AstraZeneca, another drugmaker producing a potential Covid-19 shot, to its roster of clients. Emergent previously promised to deliver 1 billion shots between the two by the end of this year. (Owermohle, 4/1)

When an East Baltimore plant run by Emergent BioSolutions found that a large batch of urgently needed COVID-19 vaccine had to be trashed because workers used the wrong ingredients, the company said the episode was “disappointing” but showed that its rigorous quality controls worked. That’s true, say vaccine supply chain and public health experts. Snafus are not infrequent in plants producing complex vaccines and therapeutics, and the pandemic likely added to the pressure to produce. (Cohn, 4/2)