FDA warns three baby-formula makers about production violations

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The U.S. Food and Drug Administration said Wednesday it has sent warning letters to three baby-formula makers as part of what the agency called enhanced oversight of the product, which was plagued by numerous recalls and shortages last year.

The agency did not advise caregivers to discard or avoid purchasing any particular infant formula “at this time” and said that it is not aware of any contaminated product being sold. Recent baby-formula recalls “were effective in removing the potentially contaminated batches of product from the market,” the FDA said.

“Additionally, these warning letters are not associated with any current recalls and therefore the FDA does not anticipate any impact to the availability of infant formula on the market,” it said.

Letters were sent to the privately held ByHeart Inc.; to Mead Johnson Nutrition, which is part of Reckitt Benckiser Group PLC
; and to Perrigo Co.’s
Perrigo Wisconsin, LLC. The letters reflected inspection findings over the last several months, the FDA said.

“At the time of each inspection, the FDA issued inspectional observations and exercised oversight of each firm as they initiated recalls” in December 2022, February 2023 and March 2023 to remove product potentially contaminated with Cronobacter sakazakii bacteria from the marketplace, the FDA said.

The letters are part of a “normal regulatory process,” and, among other requirements, informed the companies that they must clean and sanitize facilities and also “properly evaluate their cleaning and sanitation practices, schedules, and procedures before releasing product,” the FDA said.

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

A nationwide baby-formula shortage sent parents scrambling for the product in 2022, mostly because of product recalls involving Abbott Laboratories
earlier that year due to contamination concerns.

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