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FDA wants infant formula makers to step up efforts to prevent contamination

Top FDA official calls on infant formula makers to correct their behavior.

In a letter this week, FDA Commissioner Robert M. Califf and FDA Commissioner Susan T. Mayne Center for Food Safety and Applied Nutrition and Manufacturers, Packers, Distributors , exporters, importers and retailers spoke to address concerns about infant formula in the food chain.

“FDA is sharing this information with you in the expectation that you will take action to mitigate potential food safety risks of infant formula in accordance with FDA regulations, while furthering efforts to improve operations, especially given the critical nature of these products ,” said a letter from FDA leaders.

”. . . FDA reviewed conditions during its recent inspections of infant formula manufacturers, including routine surveillance inspections, for-cause inspections to follow up on consumer complaints, and other interactions with manufacturers. interaction.”

This letter is FDA’s response to a series of Cronobacter spp. Infants who were fed Similac and other brands of infant formula made at Abbott Nutrition’s plant in Michigan became sick.

Inspection of the facility revealed Cronobacter spp. In production environments, among other unsanitary conditions, led to a nationwide recall. The recall and months-long shutdown at the plant are the main reasons behind the nationwide shortage of infant formula through 2022.

“In response, FDA developed a strategy to prevent future Cronobacter. illnesses associated with infant formula and issued this letter to share current information to assist industry Improving the microbiological safety of infant formula,” the letter reads.

In releasing the letter, Califf and Mayne said FDA reviews food safety and operating conditions during its ongoing inspections of infant formula manufacturers. Additionally, food safety personnel have met regularly with infant formula manufacturers over the past two months to further develop prevention strategies to help prevent Cronobacter disease associated with consumption of infant formula.

As part of FDA’s proposed steps, the agency expects companies to “voluntarily notify the agency when product samples are found to be positive for Cronobacter spp. or Salmonella, even if the affected batches have not yet distribution.”

FDA is unhappy with the way companies monitor bacteria and Cronobacter indicators in their facilities, according to letters from Califf and Mayne.

“Manufacturers of infant formula must have in-process control systems covering all stages of processing designed to ensure that the product is said in the letter.

“. . . The presence or absence of EB (Enterobacteriaceae) on environmental surfaces is not a reliable indicator of the presence of Cronobacter spp. in other cases when responding to the detection of Cronobacter spp. In product In the sample, some facilities immediately sanitized suspect environmental or equipment surfaces and then took samples from Whether to lead to the ability of pollution incidents. FDA encourages companies conducting RCI (Root Cause Investigation) to thoroughly investigate potential sources of contamination by collecting environmental samples prior to performing sanitation activities, in addition to other RCI activities such as evaluating incoming ingredients and reviewing manufacturing records,” the letter said.

FDA leaders call on manufacturers to ensure that raw materials used to make infant formula are free of pathogens, or employ methods that kill pathogens, before using them.

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