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Abbott will reopen its infant formula factory on June 4

News Photo: Abbott to reopen infant formula factory on June 4

WEDNESDAY, May 25, 2022 (HealthDay News)

Beginning June 4, Abbott Nutrition will restart infant formula production at a closed factory that has been at the heart of the current infant formula shortage in the United States, the company announced Tuesday.

The plant in Sturgis, Michigan, has been closed since February for what the US Food and Drug Administration called “unsanitary conditions”. In the first three months of the year, agency inspectors detected Cronobacter sakazakii bacteria in several places inside the plant, CNN reported.

However, the recent baby formula shortage prompted a quick cleanup and reopening of the factory.

A federal judge issued a consent decree in May outlining steps Abbott needed to take to resume production, and after completing those steps, the company estimated it would take about two weeks to restart production.

The company will keep an independent expert on site to review operations and ensure the plant complies with FDA rules.

In A declaration released Tuesday, the FDA said Abbott will begin producing EleCare and other specialty metabolic formulas at the Michigan plant. The first batches should be in stores around June 20.

Abbott will also immediately make 300,000 boxes of the EleCare specialty formula already in stock available to people whose babies urgently need the hypoallergenic amino acid product, free of charge.

To ensure they are not contaminated with bacteria, “these products will undergo enhanced microbiological testing prior to release,” the FDA said in the statement. “Although certain EleCare products were included in Abbott Nutrition’s infant formula recall, these EleCare products to be marketed belonged to different batches, were never marketed and were kept under control by Abbott Nutrition.”

Parents and caregivers who need the EleCare specialty formula can ask their doctor for more information about the release or call Abbott at 1-800-881-0876.

The FDA said Tuesday it was doing “everything in its power” to ensure there is enough formula for parents and caregivers who need it.

The agency is in talks with foreign formula manufacturers and suppliers to bring their products to the United States. That includes UK-based Kendal Nutricare, which will export some of its formula to the United States, including 40,000 cans currently in stock that it could expedite and ship immediately, the FDA said.

The agency has assessed and approved the nutritional quality of the company’s products, its safety testing, and its production and control history. More than 2 million boxes of Kendal Nutricare products are expected to hit store shelves in the United States in June, the agency said.

“Our recent actions will help to further strengthen the supply of infant formula, including through the importation of safe and nutritious products from overseas based on our increased flexibilities announced last week,” said the Commissioner of the FDA, Dr. Robert Califf, in press release. “It is important to note that we expect additional infant formula to be able to be imported quickly and safely into the United States in the near term based on ongoing discussions with manufacturers and suppliers around the world.”

In the meantime, “the FDA continues to advise against making infant formula at home or diluting infant formula“The agency said. Parents and caregivers of infants are urged to consult with their child’s healthcare provider for guidance on modifying feeding practices, if deemed necessary.

“The U.S. Department of Health and Human Services has also released a fact sheet with information to help families find infant formula“, noted the FDA.

More information

The American Academy of Pediatrics has tips for parents during formula shortage.

SOURCES: US Food and Drug Administration, May 24, 2022; CNN

By Cara Murez and Ernie Mundell HealthDay Reporters

Medical news
Copyright © 2021 Health Day. All rights reserved.




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