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Emergent BioSolutions Stock Falls After FDA Initiates Inspection Of Bayview Facility

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Emergent BioSolutions Stock Falls After FDA Initiates Inspection Of Bayview Facility
  • Emergent BioSolutions Inc (NYSE: EBS) has had a tough month: First, the company ruined 15 million doses of Johnson & Johnson’s (NYSE: JNJ) COVID-19 vaccine manufactured at its Baltimore site. Then, the FDA seized the reins of the facility and passed them on to JNJ.
  • Now, as the agency receives a full accounting of the site’s problems, Emergent will cease manufacturing at its Baltimore plant until the FDA’s inspection and remediation of any findings is complete, the company said in a statement.
  • The company will also quarantine existing materials that have already been manufactured. That halt started on Friday, four days after the FDA initiated the inspection.
  • The affected drug substance didn’t make it to fill-finish, but it resulted in a significant drop in the number of doses to just 785,000 compared to 4.95 million the week before. California, Texas, and Florida were the leading recipients of the vaccines.
  • In Form 483 sent to the company, FDA investigators found the company’s quality unit failed to ensure the basic functions of its operations, including that electronic data were manipulated and deleted, and the procedures were not recorded in writing.
  • The company’s computers did not prevent users from changing the date and time.
  • Price Action: EBS shares are down 10.4% at $69.55 in market trading hours on the last check Monday.
 

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Posted-In: BriefsBiotech Government News Health Care Contracts FDA General

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