3 baby formula makers get USFDA warning letter to correct manufacturing process controls
The FDA's warning letters are not associated with any current recalls, and were related to observations following recalls by the three companies between December and March, the agency said.;
The U.S. Food and Drug Administration has 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.
The regulator issued warning letters to ByHeart Inc, Reckitt Benckiser Group's Mead Johnson Nutrition and Perrigo's Wisconsin unit.
The FDA pulled up these companies for failing to establish processes to ensure infant formula does not become contaminated during manufacturing.
"We are in the process of carefully reviewing the FDA's letter and plan to work closely with the agency," a spokesperson for Perrigo said, adding all their infant formula products that were available to parents and caregivers comply with the FDA's food safety requirements.
The FDA's warning letters are not associated with any current recalls, and were related to observations following recalls by the three companies between December and March, the agency said.
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