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Abbott Labs, FDA reach deal to reopen baby formula manufacturing plant

Abbott Labs, FDA reach deal to reopen baby formula manufacturing plant
An acute shortage of infant formula was caused in part by the closure of an Abbott Laboratories manufacturing plant in February. File Photo by Ben_Kerckx/Pixabay

May 16 (UPI) -- Abbott Laboratories, a key manufacturer of baby formula, said Monday it has reached agreement with regulators to reopen a shuttered production plant amid a nationwide supply shortage.

The company and the Food and Drug Administration said the deal will speed the resumption of infant formula production at Abbott's plant in Sturgis, Mich., which was closed in February due to consumer safety concerns.

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The proposed consent decree is subject to court approval and does not affect any other Abbott plant or operation, the company said in a release.

Abbott recalled Similac, Alimentum and EleCare powdered infant formulas made at the Sturgis facility after they were linked to infections in infants that led to two deaths.

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"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," Abbott Chairman and CEO Robert B. Ford said.

"We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage," he added. "We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years."

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The proposed consent decree "will help to safely increase the supply of baby formula for families," Attorney General Merrick Garland said.

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"The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people."

Under its terms, Abbott must retain outside expert assistance to bring its facility into compliance with the FDA and good manufacturing practice regulations.

Ford said the company could restart production at Sturgis within two weeks once the FDA confirms the initial requirements have been met, but warned it will take six to eight weeks before the products are actually available on store shelves.

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Many of those shelves have been empty in recent weeks due to the Abbott recall and other factors, leaving mothers scrambling to find ways to feed their infants.

Retailing analysts for Datasembly found that more than 40% of baby formula was out of stock in the United States during the week ending May 8, CNBC reported.

President Joe Biden met with manufacturers and retailers of infant formula last week in a bid to address the acute shortage and the White House is now taking steps making it easier to import baby formula from other countries, White House press secretary Karine Jean-Pierre told reporters Monday.

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"This one of the president's top priorities," she said. "He gets how stressful this is for parents trying to feed their children, which is why we're leaving no stone unturned to make more safe formula available."

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