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Market Chatter: Thermo Fisher Plant Breached FDA Rules, Documents Show
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Market Chatter: Thermo Fisher Plant Breached FDA Rules, Documents Show
Oct 4, 2024 8:15 AM

07:36 AM EDT, 10/04/2024 (MT Newswires) -- A Thermo Fisher Scientific ( TMO ) plant has over the past decade repeatedly breached rules meant to keep drugs free from contamination, Reuters reported Friday, citing US Food and Drug Administration documents.

The latest inspection of the Greenville, North Carolina plant in May revealed manufacturing issues with Beyfortus, a drug for respiratory syncytial virus developed by AstraZeneca and Sanofi, the report said.

The FDA inspection identified 17 shortcomings, including inadequate visual inspections for any particulate matter floating in the injectable drugs and problems with how staff handled sterile components.

The issues were resolved to the FDA's satisfaction, the report said, adding that the FDA said in a statement that it did not take or recommend regulatory or enforcement action because it was not warranted at this time.

Thermo Fisher Scientific ( TMO ) and FDA did not immediately respond to MT Newswires' request for comment.

(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)

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