Formula production at Abbott Michigan plant delayed due to severe storm flooding



Abbott said it halted production of EleCare formula at its Sturgis, Michigan plant after a severe storm caused flooding inside the plant, potentially delaying production of new formula for several weeks.

The factory restarted production less than two weeks ago after a months-long shutdown led to a shortage of formula across the country.

“Severe thunderstorms and heavy rain swept southwest Michigan Monday night, bringing high winds, hail, power outages and flood damage to the region,” Abbott said in a statement. statement Wednesday night. “These storms produced significant amounts of rain in a short period of time – flooding the stormwater system in Sturgis, Michigan and causing flooding in parts of the city, including areas of our facility.

“As a result, Abbott has discontinued production of its EleCare specialty formulation, which is in progress to assess storm damage and to clean and sanitize the facility. We have notified the FDA that comprehensive testing will be conducted in conjunction with an independent third party to ensure the facility can safely resume production. This Production and distribution of new products may be delayed by several weeks. »

Abbott said it will restart production of EleCare, then specialty and metabolic formulations, and will “restart production of Similac at the facility as soon as possible” once the facility is re-sanitized and production resumes.

exist tweet On Wednesday night, FDA Commissioner Dr. Robert Califf said: “We know Abbott is rapidly assessing the damage and will report his progress to us in the coming days. The FDA will return to the factory once the company has a plan in place. , to ensure it can quickly restart producing safe, high-quality formulated products.

The plant has been closed for months after an FDA inspection found Cronobacter sakazakii, which can be deadly to infants in several regions. Similac, Alimentum and EleCare infant formula made at the plant were recalled, and the shutdown added to shortages caused by the disruption to the supply chain. For months, families across the U.S. have struggled to find formula for babies and people with specific nutritional needs.

Califf said last month that the shuttered Michigan plant required major repairs, including replacing the roof and floors.

“You can’t open a factory with bacteria growing in it,” he told a Senate committee hearing. “I mean, if there’s germs everywhere, standing water, mud on people’s feet, are you going to go to the kitchen next door? That’s basically what the inspection shows.

In May, a federal judge signed the agreement between the FDA and Abbott that outlines the steps the company needs to take to restart production. The factory reopened on June 4.

But on Monday, severe weather moved into the upper Midwest and the Ohio Valley, including Michigan.

Califf called the recent shutdown an “unfortunate setback and a reminder that natural weather events can also lead to unforeseen supply chain disruptions”.

Abbott said Wednesday that it has “enough EleCare and most of its specialty and metabolic formulations” to meet demand before the new product hits the market. These products are distributed to households through health professionals.

Steps have also been taken to increase the availability of other types of formulations. President Joe Biden invoked the Defense Production Act to order formula ingredient suppliers to prioritize deliveries to formula manufacturers, and the administration launched Operation Flight Formula to import formula from strangers.

Califf said on Twitter Wednesday that the team is working “around the clock” to deliver the formula. Even with the Michigan plant closed, Abbott is producing more formula per month in 2021, while other producers are producing formula at an “above-average” rate, he said.

“This means that even before production resumes at the Sturgis facility, the total amount of formula available exceeds the demand for formula prior to the recall,” Calif wrote.

But many grocery store shelves are still empty. About a quarter of infant formula in the U.S. remained out of stock last week, according to market research firm Information Resources Incorporated (IRI).

The White House often cites IRI data as a measure of the severity of the shortage. The latest figures show that about 24% of infant formula was out of stock in the week to June 12, up from about 22% the week before.

Before Abbott’s nationwide recall of infant formula in February, about 10 percent of infant formula was generally out of stock.

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