FDA details issues at factory behind recalled formula

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FILE – The Abbott Laboratories manufacturing plant is shown in Sturgis, Michigan September 23, 2010. Federal safety inspectors say infant formula maker Abbott failed to maintain sanitary conditions at the Michigan manufacturing plant recently linked to a cluster of childhood illnesses. The Food and Drug Administration began investigating the plant after Abbott recalled several prominent infant formulas. FDA inspectors have been inspecting Sturgis facilities onsite since late January 2022. (Brandon Watson/Sturgis Journal via AP, File)

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Infant formula maker Abbott failed to maintain sanitary conditions and procedures at the Michigan manufacturing plant recently linked to a cluster of childhood illnesses, according to findings released Tuesday by federal safety inspectors.

The Food and Drug Administration released its first inspection results from the Abbott factory which has been linked to several infant hospitalizations, including two deaths, due to a rare bacterial infection. Abbott recalled various batches of three popular powdered infant formulas in mid-February. FDA inspectors have been inspecting facilities in Sturgis, Michigan, onsite since late January.

Abbott failed to keep surfaces used in the production and handling of the powdered formula clean, according to the FDA inspection, which ended last week. Additionally, inspectors discovered a history of contamination with the bacteria, known as cronobacter, including eight cases between fall 2019 and February this year.

The report gives the agency’s preliminary findings and is likely to be followed by a formal report and a warning to the company.

Food safety advocates following the recall noted that neither the FDA nor the company was able to explain what caused the contamination.

“It sheds a little more light on what went wrong, but we still don’t have all the answers,” said Sarah Sorscher of the Center for Science in the Public Interest. “Abbott and the FDA really need to do more work to get to the bottom of what happened so we can prevent the next outbreak.”

Abbott said in a statement that it “takes this very seriously and is working closely with the FDA to implement corrective actions.”

Abbott has not confirmed the number of recalled units, but the company’s brands include some of the world’s top-selling infant formulas, including Similac, Alimentum and EleCare. The company says it continues to produce formula at its other plants in the United States and abroad.

The recalls have exacerbated ongoing infant formula shortages due to supply chain issues.

Cronobacter infections are rare but can be fatal in babies. Almost all reported outbreaks in the United States have been linked to powdered baby formula, which does not experience the same high temperatures used to kill germs in many other foods. Manufacturers have long said that it is impossible to remove all bacteria from formulas.

There had been little new information about the recall since last month, despite requests from Senate lawmakers that Abbott turn over documents about conditions at the Michigan plant.

In a letter last month, members of the Senate Health Committee specifically asked Abbott how long it took to initiate the recall. According to the letter, Abbott first received a report of an illness linked to his formula from Minnesota health officials in September, with additional reports in the coming months from Ohio and Texas.

It’s also unclear why the FDA didn’t take action at the plant sooner. FDA inspectors visited the plant in late September and cited several issues, including unsanitary conditions, a lack of temperature screening and employees who failed to sanitize their hands. But none of the issues resulted in an official FDA warning or a requirement that Abbott stop production.

The FDA released the September inspection report Tuesday evening along with another from 2019.

In addition to its factory inspectors, the FDA has scientists at its Washington headquarters who specialize in food outbreaks related to baby foods and infant formula. A senior FDA deputy commissioner is also responsible for overseeing food safety issues.

The recalled Abbott products can be identified by examining the coding on the bottom of each container. The plans affected all have an expiration date of April 1, 2022 or later. The company has set up a website where parents can check if products have been recalled.

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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.