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FDA, Abbott Agree on Plan to Resume Production at Michigan Baby Formula Plant, Could Take Two Months Before Product Available


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The Food and Drug Administration on Monday announced it has agreed with Abbott Nutrition on a plan to reopen the company’s manufacturing plant in Sturgis, Michigan.

The FDA shut down the Sturgis formula plant three months ago due to an alleged deadly bacteria.

Abbott refuted claims that its formula was to blame for the deaths of four babies that used its formula.

The firm investigated the causes of those babies’ deaths and none were related to its formula.

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Abbot Laboratories said it reached a deal with the FDA to reopen its Michigan plant – but it could take two months before product hits the shelves.

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Abbott stated in a press release:

  • After FDA approval, Abbott could restart the site within two weeks; from the time of restart it would take six to eight weeks before product is available on shelves
  • Abbott will continue to import formula from FDA-registered facility in Ireland to help alleviate near-term supply shortage
  • CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses

Abbott (NYSE: ABT) has agreed to enter into a consent decree with the U.S. Food and Drug Administration (FDA) related to its Sturgis, Mich., infant formula plant. The decree is an agreement between FDA and Abbott on the steps necessary to resume production and maintain the facility. This does not affect any other Abbott plant or operation. The decree is subject to court approval.

“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility,” said Robert B. Ford, chairman and chief executive officer, Abbott. “We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”

Once the FDA confirms the initial requirements for start-up have been met, Abbott could restart the site within two weeks. The company would begin production of EleCare®, Alimentum® and metabolic formulas first and then begin production of Similac® and other formulas. From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves.

Abbott has been working on corrective actions since the FDA inspection and submitted a response and corrective action plan to FDA on April 8. Even before its formal response, Abbott had begun working to implement improvements and take corrective action. Some of these actions included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating protocols regarding water, cleaning and maintenance procedures at the facility. Abbott immediately implemented corrections to address the items that the FDA raised in its observations provided at the conclusion of the inspection. The company has also been making upgrades to the plant.



 

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