Milk powder maker Abbott resumes production amid US shortages | Michigan

Milk powder maker Abbott has reached an agreement with US health regulators to resume production at one of the country’s largest factories. In the nationwide shortage of mixed milk It exposed the shelves and the parents scrambled.

The agreement with the Food and Drug Administration (FDA) on Monday represents a legally binding agreement between the regulatory agency and the company on the steps required to reopen the Sturges plant. MichiganWas under investigation due to safety concerns.

However, it will take more than a month for the site to ship a new product to alleviate the situation. Abbott said it would take six to eight weeks for the formula to begin arriving at the store after production resumed.

Abbott is one of only four companies that produce about 90% of the US formula, and its brand occupies almost half of its market.

The company did not set a timeline to resume production or provide details on trading terms.

The FDA has announced additional steps to mitigate supply chain crises and said it is streamlining the review process to make it easier for foreign manufacturers to start shipping more prescriptions to the United States. I did.

“The FDA expects supplies to be in progress or in stores due to measures and measures taken with infant formula makers and others,” FDA Commissioner Robert Caliph told reporters. rice field.

Caliph said the United States prioritized companies that could provide the largest cargo and quickly documented that their formulations were safe and compliant with US nutritional standards. This policy is structured as a temporary measure that lasts for 6 months.

The Joe Biden administration is faced with strong pressure to do more to alleviate the shortage, so many parents continue to look for infant formula online and in food banks.

Abbott’s factory was scrutinized earlier this year after the FDA launched four investigations. Bacterial infectious disease in infants A person who consumes infant formula from a plant. Two babies have died.

The crisis intensified when the company stopped production in February, recalled several brands of infant formula, and squeezed supplies that had already been tightened by supply chain disruptions and stockpiles during Covid-19. Due to the shortage, retailers such as CVS and Walgreens 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.

After six weeks of inspection, FDA investigators published a list of problems at the Abbott plant in March. This includes loose safety and hygiene standards, as well as a history of bacterial contamination in some parts of the factory.

The Chicago-based company emphasizes that its products are 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.

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.

According to pediatricians, infant formula produced in Canada and Europe is about the same as in the United States. However, traditionally, 98% of the supply of infant formula in the United States is domestic. 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 Davis, had a prescription for Abbott, but was miserable to find a prescription for his medically fragile daughter who had to switch to recalls from other brands and subsequent shortages. I faced a challenge.

Zoie Davis 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. Mortgage company Davis said she was shy at the milestone by £ 4.

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

Davis said he used foreign organic brands until cost and customs hurdles made it difficult. Friends and strangers from outside the state sent him other brands, but each time she switched, more blood tests and monitoring were needed, Davis said.

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.

The shortage is especially serious for low-income parents, such as Patience, a 10-month-old daughter with allergies who require special prescriptions, such as Clara Hinton, 30, in Hartford, Connecticut.

Hinton, who doesn’t have a car, took a bus from town to town to the suburbs and finally found some suitable ceremonies at the West Hartford box store. But she said her store refused to receive food stamp cards, and she recently ran out of prescriptions from an already opened can she got from her friend.

“She has no formula,” she said. “I made her drink regular milk. What do I do? Her pediatrician revealed that I wasn’t supposed to do that, but what did I do? Do you? “