Less than two weeks after reopening its baby formula plant in Michigan, Abbott Laboratories was forced to stop production again – this time because of severe flooding.
Torrential rain from severe storms overwhelmed the stormwater system in Sturgis – which caused flooding in the city on Monday. Abbott’s plant that produces baby formula was shut down because it suffered flood damage.
“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 in a statement released on Wednesday. “We have informed FDA 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.”
Abbott noted that the plant would not reopen until it has been cleaned and re-sanitized. Once the plant reopens, it will begin producing EleCare – an amino acid-based, hypoallergenic formula for babies.
“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 statement read.
FDA Commissioner Robert Califf personally spoke with Abbott CEO Robert Ford and gave an update on the flooded plant during a Senate hearing on Thursday.
“We have twice-daily intensive calls about all the work on the infant formula issue,” Califf said. “And at the end of the call yesterday, I commented it was one of the first days that we hadn’t had any surprises. Twenty minutes later, the email came across about the flood in Sturgis.”
“We had hoped to have a super supply so that we get the shelves completely restocked,” Califf continued. “The estimate is perhaps two weeks, but it’s too early to give an exact estimate of what the delay will be in the Sturgis plant.”
Califf said he and Ford have a “shared desire to get the facility up and running again as quickly as possible.”
Califf wrote on Twitter, “While this is an unfortunate setback and a reminder that natural weather events can also cause unforeseen supply chain disruptions, I want to reassure consumers the all-of-government work to increase supply means we’ll have more than enough product to meet current demand.”
“We know Abbott is working quickly to assess the damage and will be reporting its progress to us in the days ahead,” the FDA commissioner said. “Once the company establishes a plan, FDA will be back in the facility working to ensure that they can restart producing safe and quality formula products quickly.”
The Michigan plant only reopened on June 4 after it was shut down in February. The factory was closed down for nearly four months because of complaints of infants becoming sick from bacterial infections while consuming formula produced at the Sturgis plant.
The Washington Post reported last week, “The Food and Drug Administration investigated reports that as many as nine children have died since early 2021 after consuming baby formula produced at an Abbott Nutrition plant in Michigan — seven more than previously acknowledged by the FDA, according to newly released documents.”
Abbott told Fox Business that “there is no causal relationship between Abbott’s products and the reported deaths” from cronobacter sakazakii bacterial contamination.
“Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for cronobacter sakazakii or salmonella,” the company said. “All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for cronobacter sakazakii and/or salmonella. No salmonella was found at the Sturgis facility.”
An FDA spokesperson said, “There is no scientific evidence linking the other seven deaths with the evidence from those case complaints and our investigation of the Abbott Nutrition Sturgis plant, including extensive product testing, which is why these additional complaints were not previously made public in connection with the Abbott investigation.”
Abbott issued a recall of EleCare and other specialty formulas in February after reports of the sick infants surfaced.
The recall and plant closure caused the nationwide baby formula shortage.
President Joe Biden invoked the Defense Production Act in May to help increase the production of baby formula.