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Is FDA to Blame for Baby Formula Shortage? Agency Refuses to Reopen Country’s Largest Baby Formula Plant


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“The biggest baby formula supplier in the U.S. has denied its Michigan plant is responsible for the deaths of two children despite the FDA closing it down,” the Daily Mail reports.

The plant was shutdown nearly three months ago after a bacterial infection caused the deaths and other serious illnesses.

Abbott Laboratories issued a nationwide baby formula recall in mid-February and ceased operations at its plant in Sturgis, Michigan amid reports of babies contracting bacterial infections from its products.

Although an Abbott spokesperson said a ‘thorough investigation’ revealed infant formula produced at Sturgis facility is likely not the source of infection, the FDA refused to say when the plant can resume operations.

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The plant’s closure has fueled the nationwide baby formula shortage.

From Daily Mail:

The FDA – which said it found food safety violations at the plant, as well as five strains of Cronobacter, a bacteria that can cause blood infections and meningitis – has refused to say when the plant can resume operations.

Abbott claims they are ‘working closely with the FDA to restart operations’ at the plant, with the spokesperson noting: ‘We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall’.

The FDA told DailyMail.com it was holding discussions with ‘Abbott and other manufacturers to increase production of different specialty and metabolic products’ but refused to say when the Sturgis plant could reopen.

The formula shortage, which has become a national crisis, was triggered by supply chain issues, but spiked with the closure of the Abbott plant.

Abbott alleges that none of the formula distributed to consumers tested positive for Cronobacter or Salmonella.

The manufacturer claims the FDA and Abbott officials both tested retained products for the bacterias and yielded negative results.

Abbott notes no trace of Salmonella was found at the Sturgis plant and the Cronobacter that was found in environmental testing during the investigation was in non-product contact areas of the facility.

The company alleged the traces of Cronobacter at their plant have ‘not been linked to the two available patient samples or any other known infant illness.’

February’s recall, which is isolated to powder formulas, including Similac, Alimentum and EleCare, manufactured only at the Sturgis plant has significantly disrupted the supply chain.

The nationwide share of out-of-stock baby formula hit 40 percent in April. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50 percent.



 

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