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Manufacturer of baby formula Abbott resumes production amid shortages in the US Michigan

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Baby formula maker Abbott has reached an agreement with US health regulators to resume production at its largest domestic factory against the background of a nationwide shortage of formulas that left the shelves bare, and the parents scrambled.

Monday’s agreement with the Food and Drug Administration (FDA) is a legally binding agreement between regulators and the company on the steps needed to rebuild the Sturgis plant. Michiganwho was under investigation for security reasons.

However, it will be much more than a month before any new products are shipped from the site to help alleviate the situation. Once production resumes, Abbott said it will take six to eight weeks before the formula begins to arrive in stores.

Abbott is one of four companies that produce about 90% of American formula, and its brands occupy nearly half of that market.

The company did not set a deadline for restarting production and did not offer more information about the terms of the deal.

The FDA is expected to announce additional steps Monday to allow more foreign imports to the U.S. to address supply problems. This comes at a time when the Joe Biden administration is facing strong pressure to do more to alleviate the shortage that has forced many parents to look for mixes online or in food banks.

The Abbott plant came under close scrutiny earlier this year after the FDA launched an investigation into four bacterial infections among infants who consumed a powder mixture of the plant. Two of the babies died.

The crunch intensified when the company stopped production in February and recalled several brands of powdered formula, squeezing supplies that were already limited due to supply chain disruptions and stockpiling during Covid-19. The shortage has forced retailers, such as CVS and Walgreens, to limit the number of containers that customers can buy for each visit.

Outrage over the issue quickly grew and gave Republicans a new point to talk against Biden ahead of the November by-elections.

After a six-week inspection, FDA investigators released a list of problems at the Abbott factory in March, including unfulfilled safety and sanitation requirements and a history of bacterial contamination in several parts of the plant.

The Chicago-based company stressed that its products were not directly linked to bacterial infections in children. Bacterial samples found at his plant did not match strains collected from children by federal investigators. The company has repeatedly stated that it is ready to resume production.

The shortage of infant formula across the country has forced parents and guardians to seek resources. Photo: Jim Watson / AFP / Getty Images

Former FDA officials say fixing the problems identified at Abbott’s plant takes time, and baby formulas are receiving more attention than other food businesses. Companies need to thoroughly clean facilities and equipment, retrain staff, repeatedly inspect and document the absence of pollution.

On Monday, FDA Commissioner Robert Calif told ABC News that an announcement was being made to import the infant formula from abroad. The key issue is that the instructions for the formula be in languages ​​that are understandable to mothers and caregivers, he noted.

Pediatricians say that infant formulas manufactured in Canada and Europe are roughly equivalent to those in the United States. But traditionally 98% of infant formula supplies to the U.S. are made domestically. Companies seeking to enter the U.S. face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.

San Diego’s father Stephen Davis faced difficult problems finding a formula for his medically fragile daughter who used the Abbott formula, but was forced to switch due to the recall and subsequent shortage of other brands.

Zoe Davis was born 19 months ago without a kidney, a rare life-threatening condition that requires dialysis and tube feeding until she weighs enough for a kidney transplant. She is four pounds ashamed of this stage, said Davis, a mortgage lender.

“Her life depends on her weight gain,” he said.

Davis said he used the organic brand from abroad until costs and customs hurdles made it too difficult. Davis said friends and strangers from abroad sent him other stamps, but every time she switches, more blood tests and monitoring are required.

Despite the problems, Zoe walks, talks and “pretty well” does other stages of development, Davis said.

“She shines a light in my life,” he said.

The shortage is especially felt by low-income parents such as 30-year-old Clara Hinton of Hartford, Connecticut, who has a 10-month-old daughter, Patience, who has allergies that require special formula.

Hinton, who has no car, was riding a bus to the suburbs, driving from town to town, and finally found some suitable formula at a store in West Hartford. But she said the store refused to pick up her food stamp card, and she recently ran out of a mix of already-opened jars she had received from a friend.

“She doesn’t have a formula,” she said. “I just planted it on plain milk. What am I doing? Her pediatrician made it clear that I shouldn’t do it, but what should I do? ”

https://www.theguardian.com/us-news/2022/may/16/abbott-restart-production-baby-formula-shortage

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