US FDA Urges Baby Formula Makers to Improve Manufacturing Controls

The US Food and Drug Administration (FDA) has issued warning letters to three infant formula makers, ByHeart Inc, Mead Johnson Nutrition (a unit of Reckitt Benckiser Group), and Perrigo's Wisconsin unit, for failing to establish adequate manufacturing processes to prevent bacterial contamination. The FDA does not anticipate any impact on the supply of infant formula. The warning letters were issued following recalls by the companies between December and March, which aimed to remove potentially contaminated products from the market. The FDA believes that the recalls were effective in addressing the issue. Infant formula manufacturing has faced increased scrutiny since last year's shortage caused by bacterial infections and recalls at Abbott Laboratories' facility in Michigan.