The FDA announced an update on its ongoing work to increase the supply and availability of infant formula since the closure of Abbott Nutrition’s Sturgis in Michigan. A proposed consent decree of permanent injunction between the FDA and Abbott Nutrition and three Abbott principals was filed in the U.S. District Court for the Western District of Michigan. Under the consent decree, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility. When the company decides to restart production at this facility, it must conform to the provisions of the proposed consent decree and meet FDA food safety standards. If contamination is identified, the company must notify the FDA, identify the source of the problem and conduct a root-cause investigation before resuming production. Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations. The FDA is also working to increase production by other manufacturers. Gerber has increased the amount of their infant formula available to consumers by approximately 50% in March and April, and Reckitt is supplying more than 30% more product year to date. The FDA denies the shortage, claiming that it may be less variety than before the recall. The FDA expects supply to continue to improve over the next couple of months. @
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