The FDA is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of the Covid-19 vaccine, the company says.
The Baltimore factory was shut down by the FDA in mid-April due tothat forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson. The bulk vaccine was contaminated with an ingredient for AstraZeneca’s COVID-19 vaccine, which was being made in the same factory.
Since April, FDA inspectors have combed the factory and reviewed security camera footage to identify lapses in handling material inside the factory and worked with Gaithersburg, Maryland-based Emergent to resolve a host of problems, including unsanitary conditions and poorly trained workers. Emergent is one of several J&J contractors that produce its one-shot vaccine in bulk. The concentrated vaccine then is shipped to other factories for final steps, including diluting them to the correct strength, putting them in vials and packaging them up.
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