FDA Warns Three Baby-Formula Makers Over Violations in Production

By Sabela Ojea

The U.S. Food and Drug Administration issued warning letters to baby-formula manufacturers Reckitt & Benckiser's Mead Johnson Nutrition, Perrigo Wisconsin and ByHeart over their infant formulas.

The U.S. regulator said the three companies violated infant formula regulations, based on data compiled from a number of inspections of their facilities over the past few months.

Each company will have 15 working days to explain what corrective actions they are taking, the FDA said.

The FDA isn't advising parents and caregivers to discard or avoid purchasing any particular infant formula at this time. However, its aim is to make sure infant formula is being produced "under the safest conditions possible."

"The FDA is issuing these letters...to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA's laws and regulations," it said.

In December of last year then again in February and March, the FDA initiated formula recalls to remove product potentially contaminated with the bacteria Cronobacter sakazakii.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

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August 30, 2023 17:12 ET (21:12 GMT)

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