The Food and Drug Administration reached an agreement with Abbott Laboratories on Monday on the steps needed to reopen the company’s closed milk powder plant. Insufficient milk powder It scared and resented parents all over the country.
The FDA must give approval to resume production at the Sturgis, Michigan plant, even after the company has taken steps. Several babies who consumed the formula produced there became ill, and two became ill and were closed from February. Died.
Abbott described the agreement with the FDA as a “consent decree” and said it would require federal court approval. When the agency allowed the factory to reopen, the company said production would begin within about two weeks and could be converted to more prescriptions on the shelves in six to eight weeks. The company said it would continue to fly formulas from its Irish plant.
It was unclear how soon the FDA would approve the restart of the plant.
Abbott’s factory has been offline since February when the FDA discovered a deadly bacterium called Cronobacter while wiping in and near the production line. Abbott disputes its characterization, saying that the bacteria were found in the “high care” area, which indicates the proximity of the open product, but not necessarily in or above the production line itself. I did.
The same type of bacteria is associated with four recent infant illnesses and two deaths in Minnesota, Texas, and Ohio. “There is no conclusive evidence to link Abbott’s prescription to these infant illnesses,” Abbott said.
The closure of the factory exacerbated the existing supply crisis as parents rushed to buy infant formula. Infants are said to have important sources of nutrition from birth to their first birthday, as the shelves of stores are exposed in some communities, but desperate oatmeal serials. And some give infants fruit juice.
In addition to the FDA’s actions, Connecticut Democrat Rosa DeLauro will introduce a bill in an interview on Monday to facilitate the process of importing infant formula from foreign plants regulated by the FDA. Said that. She also said she would hold a hearing at the house to consider what went wrong in the preparatory stage for finding and deficient bacteria.
“To move forward, both the company and the FDA need to be held accountable,” says De Lauro. She called for an investigation by a health and welfare inspector, and said she had invited Abbott to testify at a hearing on May 25.
The problem at the Abbott Sturges plant surfaced in September, when the FDA conducted its first routine inspection since the Covid-19 pandemic began. According to official documents, inspectors found water standing in the factory and staff using formula milk directly without proper hand hygiene.
next month, Whistleblower A person working at the factory complained that under the Food Safety Modernization Act, factory leaders celebrated the hiding of information from the FDA and omitted important information from official documents.
According to FDA records, the FDA returned to the factory on January 31 and discovered persistent problems, including the presence of Cronobacter near the production line.
The FDA and Abbott discontinued production on February 17, issuing an extensive recall of Abbott’s infant formula. New or unfamiliar taste.
Dr. Robert, FDA Commissioner, Monday morning. At CNN, M Caliph said the agency is working on the supply chain to bring the required prescriptions back to the store.
Navigating infant formula shortage in the United States
“We really expect things to return to normal within a few weeks, as you know,” said Dr. Caliph.
Dr. Caliph also pushed back reports on the extent of the shortage. He described what happened after the outage as “relatively unpredictable results.” He also mentioned the supply numbers cited in several reports. 56 percent normalSaid “incorrect,” and said the White House numbers were more accurate. White House officials show that inventory rates are close to 80%, according to data from retail research firm IRI.
None of these numbers seemed to be related to Sacramento’s Angela Coleman, 32, who found a shelf for a local target that was completely stripped of infant formula on Monday. She said the only item in stock was infant formula. She drove 16 miles to a store near her parents’ house and got the last two cans of her 9-month-old son’s favorite formula.
“You want to buy it whenever you see it, because you don’t want to be at that point when you’re exhausted,” she said. Most retailers have restrictions on the purchase of infant formula.
Dr. Caliph will be present on Thursday in front of the House Expenditure Committee to answer parliamentary questions. He said in an interview with CNN that the agency had nine staff focused on infant formula and was funded by four more.
“You’ll need more,” said Dr. Caliph. “We are very worried about it because this is a big part of the well-being of Americans and our most vulnerable toddlers.”