Emergent Plant Will Remain on Hold Following FDA Inspection

(Bloomberg) -- Production at an Emergent BioSolutions Inc. facility in Baltimore will remain on hold, U.S. regulators said, following an inspection that turned up several manufacturing problems.

Emergent is a contract manufacturer that is expected to produce the Johnson & Johnson Covid-19 vaccine, but output there has been paused while officials from the U.S. Food and Drug Administration scrutinize its operations.

In an inspection report posted on the agency’s website on Wednesday, the FDA found Emergent failed to thoroughly investigate unexplained discrepancies, including the cross-contamination of a vaccine substance batch with vaccine ingredients from another client.

“There is no assurance that other batches have not been subject to cross contamination,” FDA inspectors wrote.

The FDA said in a statement that already-manufactured vaccines will undergo additional testing and evaluation to ensure their quality before distribution. The agency said that no Covid-19 vaccine manufactured at the plant has been distributed for use in the U.S.

Emergent didn’t immediately respond to request for comment on the findings. Shares of the company rose 0.9% at 9:44 a.m. in New York.

The FDA said that the actions Wednesday are unrelated to the review of safety data after “extremely rare” cases of blood clots that took place in a small number of individuals after they received the J&J vaccine.

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