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The U.S. FDA says Abbott’s milk powder plant will reopen in a week or two.

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Washington — Abbott Laboratories and the US Food and Drug Administration will reopen Abbott’s milk powder manufacturing plant in Sturgis, Michigan within a week or two, FDA Commissioner Robert Calif said Thursday.

Abbott, the largest milk powder supplier in the United States, including Similac, agreed with the FDA on Monday on the steps needed to resume production at the plant.

“Today we have already made great strides and will open within two weeks, perhaps two weeks from next week,” Caliph told the US House of Representatives. Representative panel.

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The company recalled infant formula and closed the factory in February after four infants were reported to be infected with Cronobacter sakazaki, creating a shortage among multiple manufacturers that began with a pandemic supply chain problem. I made it worse. The FDA has launched an investigation in response to consumer complaints.

Authorities cannot conclude whether the case of the sick baby is directly related to the Abbott factory until the investigation is completed, according to Caliph.

“Abbott has solved many problems,” said Caliph, three days after working closely with the FDA.

The FDA is convinced that more products “could soon hit US stores,” but he said it would take weeks for the formula supply to return to normal. He added that people are now buying more formulas than they were before the recall, making distribution difficult.

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Due to the national shortage, parents are struggling to feed their babies, and the US government is working on long-term solutions while seeking short-term solutions.

President Joe Biden enacted the Defense Production Act on Wednesday to help manufacturers obtain raw materials to increase their supply.

Biden also instructed US agencies to bring formulas from abroad into the United States using commercial aircraft contracted by the US Department of Defense, which he called the Operation Fly Formula.

The White House announced the first shipment of the Operation Fly Formula on Thursday. An eight-ounce bottle, equivalent to 1.5 million bottles of the Nestlé SA Formula, will be shipped from Zurich, Switzerland, to Plainfield, Indiana. The three formula brands shipped are for children with milk protein allergies.

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On Wednesday, the House passed two bills, including one that provided $ 28 million in emergency FDA funding, backed by 219 Democrats and 12 Republicans. It was opposed by 192 Republicans.

The second measure passed 414-9 is that low-income families can continue to use their interests to purchase formulas under a federal program for women, infants and children known as WIC. Will guarantee.

Both bills are still facing voting in the tightly divided Senate.

‘Dereliction of duty’

House Expenditure Committee Chair Rosa De Lauro burned a caliph that appeared before the Expenditure Subcommittee to discuss the FDA’s budget requirements for fiscal year 2023 over the response to the shortfall.

The FDA said on Monday that it would allow the import of infant formula from foreign manufacturers that normally do not sell products in the United States to alleviate the shortage.

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“I’m still concerned about the safety of formulas that will eventually be placed on the shelves,” said De Lauro, “recently released FDA guidance to ensure the safety of formulas.” Not enough. “

Caliph said the formula will only be imported after the FDA has determined it is safe.

De Lauro also criticized the FDA for acting too late after receiving a whistleblower report in October. De Lauro quoted the report last month when he asked for a government investigation.

“Whomever looked at the report and felt that he didn’t have to respond at all from October to February until the recall occurred. In my view, it’s a neglect of duty,” she said.

Caliph said the U.S. was stressed in the formula supply chain before the February recall of Abbott due to factors such as the pandemic, but improved how quickly the FDA would respond to such issues. Said that there was room for.

“We were able to do better than ourselves.”

(Report by Ahmed Aboulenein and Susan Heavey, edited by Chizu Nomiyama, Lisa Shumaker, Leslie Adler)


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The U.S. FDA says Abbott’s milk powder plant will reopen in a week or two.

Source link The U.S. FDA says Abbott’s milk powder plant will reopen in a week or two.

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