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Top Republicans say slow-acting FDA delayed formula plant reopening

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FDA officials dragged their feet on letting Abbott Nutrition reopen its Sturgis, Michigan, baby formula plant after it was closed to address safety and quality …
FDA officials dragged their feet on letting Abbott Nutrition reopen its Sturgis, Michigan, baby formula plant after it was closed to address safety and quality issues, top House Republicans said Thursday, citing information from industry insiders. Abbott closed the facility in February following a formula recall and while FDA conducted a multi-week inspection that discovered five strains of Cronobacter sakazakii, and other safety concerns. But those concerns were quickly addressed, Republican lawmakers say, and yet the plant remained closed even as America’s supply of baby formula dried up over the spring. According to the Centers for Disease Control and Prevention (CDC), Cronobacter sakazakii is a germ found naturally in the environment that can live in dry foods including powdered infant formula, powdered milk, herbal teas and starches. None of the strains in the Abbott factory matched genotypes of bacteria found in two of four infants who were sickened after consuming powdered formula from the plant. Abbott officials said they submitted a response to the problems the FDA cited in its inspection of the plant, and sent a “corrective action plan” to the FDA on April 8. SEE ALSO: Biden announces first foreign formula shipment

Yet six weeks later, the factory remains closed, despite having previously produced most of America’s supply of Similac, the most popular infant formula, as well as the entire national supply of specialty formulas for infants with unique feeding needs.
“We have heard from folks in the industry that the FDA went silent for months and there was no engagement,” House Republican Conference Committee Chair Elise Stefanik, a New York Republican whose nine-month old baby is formula-fed, told The Washington Times.
“The plant addressed all the concerns from the FDA, even though they argue that it didn’t come from the facility,” she said. Neither Abbott nor FDA officials have disclosed why the plant was not cleared to re-open after the company proposed the corrective action plan on April 8. The agency was under intense pressure from Democrats in Congress to take action against the plant. Rep. Rosa DeLauro, Connecticut Democrat and House Appropriations Committee chair, had begun calling a month earlier for the Health and Human Services Inspector General to begin investigating the FDA for “acting too slowly.”
She wanted Abbott to pull infant formula from the shelves after the handful of infants became ill beginning the previous fall. Ms. DeLauro requested the investigation into the FDA’s actions on March 4. She said the FDA had inspected the plant in September and had discovered violations of safety protocols meant to prevent contamination of formula, four months before urging Abbott to recall formula and shut down the plant.
“The delay between the September inspection and the recall raises serious questions about the FDA’s ability to adequately regulate the infant formula industry,” Ms. DeLauro wrote to FDA Inspector General Christi Grimm.
“It seems evident that the FDA could have acted sooner to prevent additional illnesses and deaths after the initial inspection,” she said. FDA Commissioner Robert M.

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