Abbott Nutrition again pauses baby formula production in Sturgis

Less than two weeks after resuming production amid a recall tied to a national baby formula shortage, manufacturer Abbott Nutrition announced Wednesday it is again pausing operation for some products at its Sturgis facility.

In a statement, Abbott said severe weather and rainfall that reached the state's southwest side of Michigan this week overwhelmed the city's stormwater system and resulted in flooding in areas of the plant.

"As a result, Abbott has stopped production of its EleCare specialty formula that was underway to assess damage caused by the storm and clean and re-sanitize the plant," Abbott said.

"We have informed (the Food and Drug Administration) and will conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production. This will likely delay production and distribution of new product for a few weeks."

The city of Sturgis provided further details about the flooding incident on Thursday. A "significant storm event" triggered several intervals of heavy rainfall over a short period of time, briefly putting the storm sewer system at capacity, according to a statement from the city. 

Abbott contacted the city directly to notify officials that their facility had flooded during the storm, Sturgis Assistant City Manager Andrew Kuk said in a statement. 

A surge of storm water pushed both the municipal sewer system and Abbott's on-site drainage system to capacity, Kuk said.

"This combination of factors is an extremely rare occurrence," Kuk said. "All storm water capacity issues were cleared in a matter of hours as the storm decreased and systems were able to catch up."

Abbott closed the Sturgis factory in February after the FDA said it began investigating four bacterial infections among infants who consumed powdered formula from the plant. Two of the babies died.

The company continues to say its products have not been directly linked to the infections, which involved different bacterial strains.

The shutdown of the largest formula factory in the country led to the supply problems that have forced some parents to seek formula from food banks, friends and doctor's offices.

The February recall of several leading brands, including Similac, squeezed supplies that had already been strained by supply chain disruptions and stockpiling during COVID-19 shutdowns.

The shortage has been most dire for children with allergies, digestive problems and metabolic disorders who rely on specialty formulas. The Abbott factory is the only source of many of those products, providing nutrition to about 5,000 U.S. babies, according to federal officials.

Abbott is one of four companies that produce about 90% of U.S. formula. The company’s recalls and shutdown triggered a cascade of effects: Retailers have limited customer purchasing to conserve supplies and parents have been told to switch brands to whatever formula is in stock.

FDA inspectors eventually uncovered a host of violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols. The FDA has faced intense scrutiny for taking months to close the plant and then negotiate its reopening. Agency leaders recently told Congress they had to enter a legally binding agreement with Abbott to assure all the problems were fixed.

Last month, the U.S. Department of Justice confirmed a tentative agreement with Abbott to resolve safety issues at its facility. Production resumed on June 4. 

The Washington Post reported last Friday that the FDA investigated reports that as many as nine children have died since early 2021 after consuming baby formula produced at the plant — seven more than previously acknowledged by the federal agency, according to newly released documents. The agency acknowledged last Friday it had received additional reports of children dying or being sickened after allegedly drinking formula made there than the four it initially reported.

Abbott has said it initially would prioritize the production of its EleCare specialty formulas, which are hypoallergenic and used by infants and children who have severe food allergies or gastrointestinal disorders that require amino acid-based formulas. The product was not part of the February recall. 

The company said it would take about three weeks before new formula from the plant begins getting to consumers.

"Based upon historical demand and current projections, Abbott has ample existing supply of EleCare and most of its specialty and metabolic formulas to meet needs for these products until new product is available," the company said Wednesday. "These products are being released to consumers in need in coordination with health care professionals."

Abbott said EleCare production would restart after the plant is re-sanitized and production resumes, "followed by specialty and metabolic formulas. In parallel, we will work to restart Similac production at the plant as soon as possible."

On Monday, the company said it would be importing 1.1 million pounds of powder infant formula to the U.S. from its manufacturing facility in Granada, Spain, starting this month.

Associated Press contributed.

mhicks@detroitnews.com.