Washington (AP) — US officials agreed on Monday to allow milk powder maker Abbott to reopen its largest factory in the country, but it will take more than two months for new products to ship from the site. .. Country shortage Facing my parents.
Under the agreement, Abbott will need to work with outside experts to upgrade standards and reduce bacterial contamination at a facility in Sturgis, Michigan, which the Food and Drug Administration has been investigating since earlier this year. This transaction, which needs to be considered by a federal judge, represents a legally binding agreement between the FDA and the company on the steps required to reopen the factory.
This agreement was submitted to court by the US Department of Justice on behalf of the FDA.
After production resumed, Abbott said it would take eight to ten weeks for new products to begin arriving in the store. The company had not set a schedule for resuming production. This must be allowed by the FDA.
The FDA announced additional steps on Monday night, with more foreign imports into the United States Supply problems.. Many parents continue to look for infant formula online or in food banks as President Joe Biden’s administration faces strong pressure to do more to alleviate the shortage.
Abbott’s plants were scrutinized in January when the FDA began investigating four bacterial infections in infants who consumed powdered milk from the plants. Two babies have died.
In February, the company Stop production and recall some brands Milk powder, squeezed products that had already been tightened by supply chain disruptions and stockpiles during COVID-19. Due to the shortage, retailers such as CVS and Walgreen’s are limiting the number of containers customers can buy in a single visit.
Anger over this issue quickly snowballed, handing Republicans a new issue to use against Biden prior to the November midterm elections.
Abbott is one of only four companies that produce about 90% of the US formula, and its brand occupies almost half of its market.
After six weeks of inspection, FDA investigators published a list of issues in March, including loose safety and hygiene standards, and a history of bacterial contamination in some parts of the plant.
Chicago-based Abbott emphasizes that the product is not directly related to bacterial infections in children. Bacterial samples found at the factory did not match the strains collected from the baby by federal investigators. The company has repeatedly stated that it is ready to resume production until the FDA’s decision is made.
Former FDA officials say it takes time to fix the types of problems found at Abbott’s factories, and infant formulas are being scrutinized more than other food facilities. Companies need to thoroughly clean facilities and equipment, retrain staff, and repeatedly test and document pollution-free.
On Monday, FDA Commissioner Robert Caliph told ABC News that an announcement was approaching regarding the import of infant formula from abroad. The key issue, he said, is to make sure that the prescribing instructions are in a language that mothers and caregivers can understand.
According to pediatricians, milk powder produced in Canada and Europe is similar to that in the United States, but traditionally 98% of the supply of infant formula in the United States is produced domestically. Companies looking to enter the United States face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.
San Diego’s father, Stephen Hyde, had been prescribed Abbott, but faced the dire task of finding a prescription for his medically fragile daughter who had to switch to recalling other brands and subsequent shortages. I faced it.
Zoie Hyde was born 19 months ago in a rare life-threatening condition where he had no kidneys and needed dialysis and a feeding tube until he was heavy enough for a kidney transplant.
Hyde said he used foreign organic brands until cost and customs hurdles made it difficult. Davis said friends and strangers from outside the state sent him other brands, but each time she switched, she needed more blood tests and monitoring.
Despite her challenge, Zoe walks, talks, and “does pretty good” at other developmental milestones, Davis said.
“She is the shining light of my life,” he said.
AP Medical Writer Lindsey Tanner contributed to the story from Three Oaks, Michigan.
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The United States has signed a contract to reopen a milk powder factory with shutters | Associated Press
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