“You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,” the letters sent Wednesday read.
“As noted in the FDA’s press release, we want to assure the public that all of Perrigo’s infant formula products available to parents and caregivers are safe for infant feeding, and FDA does not advise discarding or avoiding purchase of any particular infant formula,” the spokesperson added. A spokesperson for Reckitt and Mead Johnson Nutrition told “Today” that “the safety of babies is of the utmost importance to us and we can confirm that all of our infant formula products continue to meet the highest FDA standards for safety and quality.
“The FDA’s communication is part of its enhanced regulatory oversight and does not relate to any new concerns or issues, as they reflect findings from previous inspections,” the spokesperson continued, adding that to date there “are no safety or quality concerns with any Reckitt/Mead Johnson formula.”‚ “We commend the FDA for its efforts to unify the industry’s ongoing work to elevate manufacturing standards and support the Agency’s enhanced oversight.
“Providing safe and high-quality infant formula continues to be our top priority and we can assure our customers that no distributed ByHeart product has tested positive for contaminants. There is no disruption to ByHeart’s manufacturing and we currently have three production plants across the U.S. that are operating to meet the demand for our formula.”
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