Abbott Laboratories, the largest baby food company in the United States, halted production at its Michigan plant in February 2022 after reports of deadly bacterial infections.
A timeline of events shows that the shutdown occurred because the facility had previously come under scrutiny from the U.S. Food and Drug Administration (FDA).
September 2021: The FDA conducted a four-day inspection of Abbott Laboratories’ facility in Sturgis, Michigan.
The inspection report found that the facility failed to maintain clean and sanitary conditions in at least one building where baby food was manufactured, processed, packaged or stored.
FDA officials also observed poor handwashing among Abbott plant employees who “worked directly with infant formula.”
The FDA also noted one case of improper equipment maintenance and temperature control.
October 2021: A whistleblower sends the FDA a 34-page document outlining possible concerns about the Sturgis facility.
The document, released by Congresswoman Rosa DeLauro in April 2022, was authored by a former plant employee.
The employee accused the plant of lax cleaning practices, falsifying records, releasing untested infant formula and hiding information during a 2019 FDA audit, among other things.
January – March 2022: The FDA conducted multiple inspections at the Sturgis facility over the course of three months in 2022. A 10-page inspection report uncovered multiple violations at the facility.
The agency claimed the factory failed to ensure all surfaces that come in contact with infant formula were maintained to prevent cross-contamination.
The report said the facility “has not established a process control system” to ensure the baby formula “is not adulterated due to the presence of microorganisms in the formula or the processing environment.”
Officials also claimed the facility failed to disclose in an investigation report whether there was a health hazard at the facility.
In addition, the report said factory workers were not wearing the “necessary protective gear” when working directly with infant formula.
February 17: US health officials are urging parents not to use three popular formulas made at Abbott’s Michigan plant. Investigators claim the products were recently linked to bacterial contamination after one infant died and three others became ill.
Abbott voluntarily recalled several major brands and closed its Sturgis plant.
The FDA also said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died.
February 28: Abbott Laboratories expanded its recall of Similac baby formula after a second infant exposed to the powdered formula died.
April 15: Abbott releases a statement claiming it is working closely with the FDA to resume operations at the Sturgis plant.
week from 24.04: The nationwide share of out-of-stock baby food reached 40 percent. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, which appear to have been hardest hit by the shortages, reported out-of-stock rates of about 50 percent.
10th of May: Abbott issued a statement to DailyMail.com claiming that the FDA conducted a “thorough investigation,” and Abbott revealed that “infant formula made at our Sturgis facility is not the likely source of infection in the reported cases and that there has been no outbreak caused by products from the US facility’.
Abbott claims they are “working closely with the FDA to resume operations at the facility,” with the spokesperson stating, “We continue to make progress on corrective actions and will take additional actions as we work to address issues related to.” to address the recent recall.” .
The FDA told DailyMail.com it was in talks with “Abbott and other manufacturers to ramp up production of various specialty and metabolic products,” but declined to say when the Sturgis plant could reopen.
Sen. Mitt Romney has issued a letter to the FDA and the United States Department of Agriculture (USDA), urging leaders to address infant formula shortages and work to prevent future threats to infant health.
May 11: Lawmakers on Capitol Hill announce plans to hold hearing on infant formula shortage in two weeks.
Abbott announced it would take up to 10 weeks for the company to be able to ship baby formula to retailers once the Sturgis plant reopens.
Abbott also said, “After a thorough review of all available data, there is no evidence that our formulas are associated with these childhood illnesses.”
12th of May: White House Press Secretary Jen Psaki defends the government’s closure of the Abbott plant.
President Joe Biden met with executives from infant formula manufacturers and retailers to address the shortage.
May 13: Biden addresses the formula crisis during a press conference, saying, “We’re going to be putting significantly more formulas on shelves in a few weeks or less.”
The FDA said it is working to streamline a process that will bring more products to consumers – while meeting safety, quality and labeling standards
May 16: Abbott and FDA agree to reopen baby formula facility in Michigan.
However, the FDA has yet to announce a timeframe for the facility to resume production.
The FDA also introduced new measures, effective for 180 days, to increase imports of foreign-made baby formula.
May 18: Biden invoked the Defense Production Act to boost baby formula production and issued a directive for planes to bring in supplies from overseas after mounting pressure from Congress.
June 1st: In response to questions from reporters, Biden admits he was only notified of the formula shortage in April.
3rd of June: White House Press Secretary Karine Jean-Pierre is grilled by reporters about who told the President about the shortage, when he was briefed, and the process used to determine when information is at the level of the President.
She dodged several questions on the subject, not wanting to go into details.
‘There is no specific person I can name. But it’s the normal way we move forward through the regular channels. I don’t have a specific person. But that’s how it is with every topic, not just this one. It goes through normal channels, and senior White House officials usually brief him on various subjects,” she said.
June 4th: Abbott resumes production at its Michigan facility.
The facility is initially prioritizing the production of specialty and metabolic formulas, with consumers expected to see these products on store shelves around June 20th.
Abbott will then resume production of all other formulas, with the factory previously saying it will take six to eight weeks to replenish stock in stores.
12th of June: Abbott is halting production at its Sturgis, Michigan facility for the second time since February.
The facility was shut down due to severe thunderstorms and heavy rains that swept through southwest Michigan and flooded portions of the building.
Abbott said in a statement that it needed to assess the damage and disinfect the factory again, but didn’t specify how much damage the factory sustained.
Production for its EleCare specialty formula has been suspended, but the company insisted there is enough supply to meet demand until production resumes.
The company did not provide a timeframe for resuming production in its statement.
June 22: The FDA opened another investigation after another child died after allegedly consuming infant formula made by Abbott Laboratories.
According to a consumer complaint filed with the FDA on June 10, the most recent infant death occurred in January.
An Abbott spokesman told DailyMail.com on June 22 that the company was notified of the infant death last week. However, the formula maker claims “limited product and clinical information has been made available to assess the case.”
“Currently, there are no conclusions that can be drawn and no evidence to suggest a causal relationship between Abbott’s formulas and this reported case,” the spokesman said. ‘If additional information is available we will investigate this further in accordance with our complaints handling process.’
The FDA also announced on June 22 that it has reviewed and investigated a total of 129 complaints related to Abbott formula products. Of these, 119 complaints were reported after the manufacturer voluntarily recalled the product on February 17.
July 1: Production of EleCare, a specialty formula for infants with severe food allergies and digestive problems, has resumed at Abbott Nutrition’s Michigan facility.
Abbott officials said the plant is working to resume production of Similac, another popular formula product, “as soon as possible.”