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Published 6 months ago

FDA sends warning letters to three infant formula manufacturers over federal violations

  • The FDA has issued warning letters to three infant formula makers, ByHeart Inc, Mead Johnson Nutrition, and Perrigo’s Wisconsin unit, for failing to establish processes to prevent bacterial contamination during manufacturing.
  • The warning letters were not associated with any current recalls, but were based on observations following recalls made by the companies between December and March. The FDA believes that the recalls effectively removed potentially contaminated products from the market.
  • Last year's shortage of infant formula due to bacterial infections from Abbott Laboratories' facility shutdown has placed greater scrutiny on the manufacturing of infant formula.
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