Abbott has reached an agreement with the FDA to reopen its milk powder factory

On May 16, 2022, a woman purchased infant formula at Target in Annapolis, Maryland. This is due to the continuing national shortage of infant formula due to the supply chain crisis associated with the coronavirus pandemic, which is already squeezing the country’s infant formula inventory. It was exacerbated by the recall of a major product in February.

Jim Watson | AFP | Getty Images

Abbott reached an agreement with the Food and Drug Administration on Monday to help reopen its manufacturing plant in Michigan after the facility was closed due to bacterial contamination to alleviate the national shortage of infant formula. ..

Under the terms of the agreement, FDA Commissioner Robert Caliph said Abbott would correct the unsanitary conditions that led to pollution and plant closures.

In a statement, Caliph said, “The authorities will do everything possible to ensure that the baby and other specialty formulations manufactured by the company meet the FDA’s safety and quality standards. The public needs to be relieved. “

The agreement between Abbott and the FDA, called the Consent Decree, was approved by the US District Court in the Western District of Michigan on Monday. The company said Abbott could reopen its plant in Sturgis, Michigan within two weeks after the FDA approves it. However, it will take 6 to 8 weeks from the start of production for the formula to reach the store.

According to retail data tracker Datasembly, mothers are having a hard time finding infant formula with empty shelves in many stores across the United States. By the week leading up to May 8, more than 40% of infant formula was out of stock nationwide. However, the FDA said on Monday, citing data from another retail data company, Information Resources, that nearly 80% of infant formula is in stock.

The supply shortage was partially caused by the closure of the Abbott Nutrition manufacturing plant in Michigan after four infants who consumed formula from the facility became ill with a bacterial infection, two of whom subsequently died. It was done.Abbott is the largest infant formula manufacturer in the United States

The Justice Department has filed a complaint on behalf of the FDA, claiming that products manufactured at Abbott’s Sturges facility have been grown up because they were manufactured under unsanitary conditions.

Testing by the FDA has found the presence of Cronobacter sakazaki, a bacterium that can cause blood infections in factories. According to the FDA, Abbott’s internal records also show that the company destroyed some of its products due to the presence of bacteria in the factory.

In February, Abbott announced the voluntary recovery of Similac PM 60/40, Similac, Alimentum, and EleCare products manufactured at the Michigan plant. Abbott was not tested positive for bacteria in formulas distributed from plants to consumers last week, and the genetic sequences of two samples from sick infants are one with the Cronobacter strain found in plants. He said he didn’t.

According to the Justice Ministry, under a consent decree to reopen the factory, Abbott agreed to bring in outside experts to help the facility comply with food safety regulations. External experts design Abbott’s plans to reduce the risk of bacterial contamination in the plant and carry out regular assessments to ensure that the company is in compliance. According to the Justice Department, this process is under the supervision of the FDA.

If any product tests positive for Cronobacter or Salmonella, Abbott needs to resume production, dispose of the product, find the source of the contamination and fix the problem. The company cannot resume production until it is approved by the FDA... If Abbott fails to comply, he will face $ 30,000 in damages daily, in breach of an annual fine of no more than $ 5 million. The company must comply with the terms of the Consent Decree for at least five years.

Attorney General Merrick Garland said in a statement Monday that the Justice Department would actively enforce US food safety legislation.

The FDA completed the inspection in March. The Centers for Disease Control and Prevention have not found additional cases of infants infected with Cronobacter after consuming the product from a facility in Michigan.

The FDA said in a statement Monday that it is working with other infant formula makers to increase domestic production. According to drug regulators, Gerber increased the amount of infant formula available to consumers by 50% in March and April, and Reckitt Benkeiser has increased its infant formula supply by more than 30% so far this year.

The FDA also said it would increase the import of infant formula into the United States. The United States typically produces 98% of the powdered milk that consumers buy. Pharmaceutical regulators allow imports of formulations originally manufactured for overseas markets, but manufacturers must submit an application to the FDA to evaluate whether the product is safe and adequately nourished. I have.

The FDA added that it prioritizes applications from companies that indicate safety and nutritional standards and can quickly deliver large quantities of products to US shelves. Biden’s senior executive official said in a call to reporters that the imported recipes came from countries with similar regulatory standards, such as Ireland, the United Kingdom, Australia and New Zealand.

Drug regulators have also said they have increased the supply of powdered milk arriving at national ports since February, with imports increasing by more than 300% compared to last year. The FDA has worked with the US Department of Agriculture and UK and European authorities on these imports.

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Abbott has reached an agreement with the FDA to reopen its milk powder factory

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