FDA warns baby formula manufacturers over federal violations

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Three companies were given 15 days to submit corrective plans to avoid future formula shortages.

The U.S. Food and Drug administration has issued warnings to three manufacturers of baby formula over violations of safety regulations.

The agency announced Wednesday that it had sent letters to ByHeart Inc., Mead Johnson Nutrition, and Perrigo Wisconsin, LLC. after inspecting their facilities over recalls of some of their products. Regulators said the letters are a follow-up meant to reinforce the importance of instituting and maintaining appropriate actions when they detect any pathogens that may contaminate product.

"Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns," said Donald Prater, acting director of the FDA's Center for Food Safety and Applied Nutrition.

"In addition to around-the-clock regulatory work, the FDA remains steadfast in upholding the commitment to unify and strengthen the FDA Human Foods Program," the agency said in a statement."This new vision comes as a result of the agency’s review of findings and recommendations from an external evaluation conducted by the Reagan-Udall Foundation, at the request of the FDA Commissioner, following the agency’s infant formula supply chain response.

 

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