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Teva Stops Production At US Plant After FDA Concerns: Report

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  • Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has temporarily stopped drug production at its Irvine plant in California to address issues raised by the FDA after a recent inspection.

  • The Company did not specify the issues raised by the agency.

  • Bloomberg reported that the production halt followed Teva's recall of more than 2.5 million vials of drugs in recent months, many of them cancer medications.

  • The report said the vials might have been contaminated with mold owing to water leaks discovered by FDA inspectors.

  • Teva said the plant received an FDA Form 483, which lists observations of issues leading to potential FDA rule violations.

  • "We have carefully reviewed the 483 and are taking extensive actions to ensure the agency's observations are fully addressed," Teva told Reuters.

  • Related: Teva Recalls One Batch Of Topotecan After Complaint Of Glass Particulate In Vial.

  • Price Action: TEVA stock is down 1.19% at $9.58 during the market session on the last check Monday.

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