Kids' Health

Amid a shortage of infant formula, the factory was forced to close as investigators tried to identify the source of the bacteria that caused the infant’s illness.

In the middle of a whole country lack of formula milkFederal investigators have been unable to pinpoint the source or source of a rare bacteria that sickened 4 infants, 2 of whom are now deceased, all of whom consumed manufactured infant formula. at a factory in Michigan.

Abbott Nutrition’s plant in Sturgis, Mich.halted Similac production earlier this year amid reports of Cronobacter infection in four infants, all of whom had eaten formula from the factory, but the Centers for Disease Control and Prevention and the Food and Drug Administration told NBC News they found no match. between the bacterial samples taken from two of the infants and the samples from the factory.

However, CDC officials also said they were unable to obtain or test samples from two other infants who had taken Cronobacter infection and have consumed formula from the factory.

Abbott Nutrition and the FDA, which is investigating the conditions at the plant, declined to say whether other cases emerged beyond the four already reported. Cronobacter infections are rare, but can be fatal in infants. Germs can cause sepsis, a blood infection, or dangerous meningitis. Two out of four infants with reported Cronobacter cases died.

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Members of Congress have raised concerns that the FDA has acted too slowly in resolving the cases.

FDA officials told NBC News that the investigation into plant conditions is ongoing and that there are “many moving parts,” but declined to answer questions from NBC News about the investigation’s progress.

Abbott Nutrition Voluntary issued a recall on February 17 after the infant’s illness was reported.

Production at the Michigan plant, which makes the country’s three most popular brands Similac, Alimentum and EleCare, has been halted and remains on hold.

Abbott said in a statement that it “continues[s] to improve our quality and production processes to ensure that our products are free of Cronobacter Sakazakii” and “has begun to take corrective and improvement actions at the facility. ”

The company added that the lack of a genetic match between the sick babies and the formula confirmed that its own internal testing showed no link and said it found no bacteria. in any of its distributed products. The company said it is also working with the FDA to address the findings from the inspections.

According to the CDC, Cronobacter can be introduced into infant formula in a variety of ways, including after the end user has opened the container.

Abbott’s production halt has exacerbated formula shortages due to supply chain issues.

Image: Baby formula, on display at a store in Chicago on January 13, 2022, has been in short supply in many stores around the country for several months.
Baby formula, which was on display at a store in Chicago on January 13, 2022, was in short supply in many stores around the country for several months. Photos by Scott Olson / Getty

More than 30% of the most popular formulas sold out across the US last week, according to a company analysis. Assembling data, track supplies at more than 11,000 stores. Walgreens is currently limiting shoppers to just three purchases of infant and toddler formula per transaction because of “increased demand and varying supplier issues,” according to the company.

The recall

In February, the FDA and CDC reported that four infants had Cronobacter disease. According to the CDC, all four infants received infant formula from the Sturgis facility.

The CDC typically receives two to four reports of Cronobacter infections each year, and an FDA spokesperson said concern was raised when FDA staff realized that all four infants had been drinking infant formula from the same household. machine.

When FDA inspected the facility Between January 31 and March 18 to resolve the cases, inspectors found the plant was unable to “establish a system of process control covering all stages of processing.” ” to prevent pollution.

According to the inspection report, the FDA and Abbott “found evidence of Cronobacter” in the “infant powder manufacturing environment.”

This is not the first time bacteria have been detected on plants.

Company filings indicate that Abbott’s own tests detected Cronobacter in infant formula production areas eight times between fall 2019 and February 2022 and another 20 cases in May. 2, although not in the recipe itself, according to the report.

Abbott also identified Cronobacter in finished formula in September 2019 and June 2020. The company said those lots were destroyed and never distributed to customers.

The FDA inspection report also mentions how the company appears to have gone wrong with its own standard operating procedures.

Inspectors noted that there had been a consumer complaint regarding one of two deaths of infants with Chronobacter disease and the ingestion of infant formula. The report said the Abbott team “did not ask” in response to a complaint that samples from the same batch of infant formula consumed were tested to clearly deviate from the company’s procedures.

Abbott told NBC News that it tested that batch of formula during an FDA inspection earlier this year and the batch was negative for bacteria.

An earlier inspection of the plant in September 2019 also found that Abbott “did not test a representative sample” of infant formula to meet the company’s “microbiological quality standards” prior to distribution. Following discussions with the FDA, Abbott said it has updated its protocols to test from a larger number of containers.

Appropriations Committee Chairperson Rosa DeLauro, D.-Conn., has asked the Office of the Inspector General of the Department of Health and Human Services to investigate whether FDA, a sub-agency of HHS, took appropriate action and effective or not. A spokesman for the inspector general said the request was being reviewed.

As a result of recent illnesses, the FDA said it intends to engage with the CDC and state partners on the possibility of adding Cronobacter to the list of common, nationwide illnesses such as salmonella.

Currently, only one state, Minnesota, requires health care providers to report cases of Cronobacter disease to public health officials.

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After the FDA concludes its investigation of the Michigan facility, agency officials said they will “conduct a programmatic review to ensure the maximum effectiveness of relevant agency policies and programs.” to infant formula and special medical food complaints, illnesses and recalls”.

How to avoid Cronobacter

CDC officials say these Cronobacter infections provide a good opportunity to remind parents How to avoid Cronobacter infection and How to prepare and store infant formula? exactly.

Cronobacter is found naturally in the environment and can live in dry foods, including powdered, powdered and starchy formulas. CDC.

They say mothers should breastfeed if possible, as infections are even rarer in breastfed babies. All baby bottles and pump parts must be cleaned and sanitized.

Liquid formula can be an option, although it is usually more expensive.

If parents are using formula, they should make sure to wash their hands and keep the lid and scoop clean. Need to quickly close the box after use. Leftover formula should be refrigerated or thrown away after 24 hours.

If consumers want to see if a formula has been recalled, they can check the company website.

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