Published 11 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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Reuters

US FDA warns 3 baby formula makers to correct manufacturing process controls

The U.S. Food and Drug Administration on Wednesday issued warnings to three infant formula makers to correct their manufacturing processes to better catch bacterial contamination, but added it does not expect any impact on the supply.

11 months ago·United Kingdom

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The Hill

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

The Food and Drug Administration (FDA) sent warning letters to three infant formula manufacturers over violations of federal safety regulations, the agency announced Wednesday. ByHeart, Mead Johnson Nutrition and Perrigo Wisconsin were issued letters after FDA inspections of their facilities as they implemented limited recalls of some of their products over health concerns regarding the…

11 months ago·Washington, United States

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WTVB

US FDA issues warning letters to three baby formula manufacturers

(Reuters) - The U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers following inspections at their facilities over the last few months. The regulator issued these letters to ByHeart Inc, Reckitt Benckiser Group's Mead Johnson Nutrition and Perrigo's Wisconsin unit. At the time of each inspection, the FDA issued observations and oversaw each firm as they initiated recalls between December and March t…

11 months ago

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WSAU

US FDA issues warning letters to three baby formula manufacturers

(Reuters) - The U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers following inspections at their faciliti...

11 months ago

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WIBQ

US FDA issues warning letters to three baby formula manufacturers

(Reuters) - The U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers following inspections at their faciliti...

11 months ago

Read Full Article

fda.gov

FDA Issues Warning Letters to Three Infant Formula Manufacturers

The FDA is issuing warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible.

11 months ago

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