Abbott Nutrition on Monday said it has agreed to enter into a consent decree with the U.S. Food and Drug Administration related to its Sturgis, Mich., infant formula plant.
“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.
The company could start production again within two weeks, however, after the FDA confirms Abbott has met initial requirements, it will still take six to eight weeks for product to reach store shelves.
The company would begin production of EleCare®, Alimentum® and metabolic formulas first and then begin production of Similac® and other formulas.
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.
“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.”
Since the recall, the company has taken numerous measures to mitigate the supply shortage. Specifically, it has focused on production in its Cootehill, Ireland, facility to serve state Special Supplemental Nutrition Program for Women, Infants and Children (WIC) consumers.
While the company said products could begin arriving at stores within eight to ten weeks once the FDA gives approval, no specific timeline to restart manufacturing has been set.
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