Abbott, FDA enter deal over reopening of baby formula facility in Michigan

Empty shelves show a shortage of baby formula at CVS in San Antonio, Texas, May 10. Abbott Laboratories said on Monday it had struck a deal with the U.S. health regulator under which it would resume production of baby formula.

Empty shelves show a shortage of baby formula at CVS in San Antonio, Texas, May 10. Abbott Laboratories said on Monday it had struck a deal with the U.S. health regulator under which it would resume production of baby formula. (Kaylee Greenlee Beal, Reuters)



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WASHINGTON — Abbott Laboratories said on Monday it had struck a deal with the U.S. health regulator under which it would resume production of baby formula at its troubled Michigan plant in two weeks, following certain clearances.

The U.S. Food and Drug Administration began looking into the facility after complaints about bacterial infections in infants who had consumed the products.

Abbott, the biggest U.S. supplier of milk formula, in February recalled Similac and other baby formula made at the Michigan facility.

The company, which shut down production at the plant in February, said last week it could restart production of infant formula at its Michigan facility within two weeks, subject to approval from the FDA.

"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," Chief Executive Officer Robert Ford said on Monday.

Abbott said it has been working on corrective actions since the FDA inspection and submitted a response and corrective action plan to the regulator on April 8.

The company reiterated that once the FDA confirms the initial requirements for start-up have been met, the site could be restarted within two weeks.

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