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FDA Issues Warning Letter For Emergent Bio's Manufacturing Facility

Published 15/08/2022, 12:22
Updated 15/08/2022, 13:10
© Reuters.  FDA Issues Warning Letter For Emergent Bio's Manufacturing Facility

  • The FDA issued a warning letter to Emergent BioSolutions Inc (NYSE: EBS), citing certain deficiencies at the company's troubled manufacturing facility in Baltimore, Maryland.
  • The FDA pointed to equipment cleaning and maintenance deficiencies to prevent drug product contamination.
  • Reuters reported that the agency also recommended that the company review its quality control process.
  • Related: Emergent Bio Says Johnson & Johnson Breached COVID-19 Vaccine Contract.
  • Emergent had said the FDA had last inspected its facility at Camden in February earlier this month and was waiting for the agency's feedback.
  • The contract drugmaker said it was also conducting additional reviews with a third party in the meantime to ensure "delivery of medically necessary products."
  • Also Read: Emergent BioSolutions Posts Q2 Loss On Lower Sales, Q3 Forecasts Below Consensus.
  • Price Action: EBS shares closed at $30.50 on Friday.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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