FDA Finds Poor Conditions at Contractor's Plant for Making J&J's Covid-19 Vaccine

By Peter Loftus 

A contract manufacturing plant that was helping make Johnson & Johnson's Covid-19 vaccine didn't keep clean, sanitary conditions and failed to take proper steps to prevent contamination, federal health regulators said Wednesday.

The U.S. Food and Drug Administration, which inspected the plant owned by contract manufacturer Emergent BioSolutions Inc., said it completed the inspection on Tuesday and would work with Emergent to address the findings from the inspection.

Production of J&J's vaccine at the Emergent plant has been paused, and material already manufactured will undergo additional testing before it is released for potential distribution, the FDA said.

"We will not allow the release of any product until we feel confident that it meets our expectations for quality," said FDA Acting Commissioner Janet Woodcock and Peter Marks, who heads the FDA department overseeing vaccines.

The Emergent plant recently had a contamination-related mishap that ruined a batch of the main ingredient for J&J's Covid-19 vaccine. No doses were distributed from the failed batch, and the FDA hasn't authorized doses using material from the Emergent plant to be distributed.

The mishap led to J&J taking over responsibility for producing its vaccine at the Emergent plant.

(END) Dow Jones Newswires

April 21, 2021 10:14 ET (14:14 GMT)

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