by TIMELINE SHOWS HOW AMERICA’S LARGEST BABY FORMULA PLANT STOPPED PRODUCTION
Abbott Laboratories, the largest supplier of infant formula in the United States, halted production at its Michigan plant in February 2022 due to reports of fatal bacterial infections.
A timeline of events shows that the closure was that the facility had previously been under investigation by the US Food and Drug Administration (FDA).
September 2021: The FDA conducted a four-day inspection of the Abbott Laboratories facility in Sturgis, Michigan.
The inspection report revealed that the facility ‘failed to maintain’ clean and sanitary conditions in at least one building that manufactured, processed, packaged or held baby formula.
FDA officials also observed poor hand washing among employees at the Abbott facility who “worked directly with formula.”
The FDA also noted one instance of improper equipment maintenance and temperature control.
October 2021: A whistleblower sends the FDA a 34-page document detailing potential concerns with the Sturgis plant.
The document, which was made public by Congresswoman Rosa DeLauro in April 2022, was written by a former factory employee.
Among other things, the employee accused the facility of lax cleaning practices, falsifying records, releasing untested infant formula and withholding information during a 2019 FDA audit.
January – March 2022: The FDA conducted multiple inspections at the Sturgis facility over the course of three months in 2022. A ten-page inspection report revealed multiple violations at the facility.
The agency alleged that the plant failed to ensure that all surfaces that come into contact with infant formula were maintained to prevent cross-contamination.
The report says the facility “did not establish a system of process controls” to ensure that the baby formula “does not become adulterated due to the presence of microorganisms in the formula or the processing environment.”
Officials also alleged that the facility failed to disclose in an investigative report whether a health hazard existed at the facility.
In addition, the report said plant workers were not wearing the “necessary protective equipment” when working directly with formula.
February 17: US health officials are urgently warning parents against using three popular baby formula products produced at the Abbott factory in Michigan. Investigators say the products were recently linked to bacterial contamination after an infant died and three others fell ill.
Abbott voluntarily recalled several major brands and closed the 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 baby formula died.
April 15: Abbott releases a statement claiming it is working closely with the FDA to resume operations at the Sturgis facility.
The week of April 24: The nationwide proportion of sold-out baby formula reached 40 per cent. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, apparently hardest hit by the shortage, reported sold-out prices of about 50 percent.
May 10: Abbott releases a statement to DailyMail.com claiming “thorough investigation” by the FDA and Abbott revealed “infant formula produced at our Sturgis facility is not the likely source of infection in the reported cases and that it was not an outbreak caused by products from the facility’.
Abbott claims it is “working closely with the FDA to restart operations” at the facility, with the spokesperson noting, “We continue to make progress with corrective actions and will implement additional actions as we work toward addressing issues related to the recent recall “.
The FDA told DailyMail.com it was holding discussions with “Abbott and other manufacturers to increase production of various specialty and metabolic products,” but declined to say when the Sturgis facility might reopen.
Sen. Mitt Romney issued a letter to the FDA and US Department of Agriculture (USDA) urging leaders to address the formula shortage and work to prevent future threats to infant health.
May 11: Lawmakers on Capitol Hill announce plans to hold a hearing in two weeks on infant formula shortages.
Abbott announced that it would take up to ten weeks for the company to get baby formula to retailers when the Sturgis facility reopens.
Abbott also said, “After a thorough review of all available data, there is no evidence to link our formulas to these infant diseases.”
May 12: White House press secretary Jen Psaki defends the government’s shutdown of the Abbott facility.
President Joe Biden met with executives from infant formula manufacturers and retailers to address the shortage.
May 13: Addressing the formula crisis during a press briefing, Biden said, “We’re going to have significantly more formula on the shelves in a matter of weeks or less.”
The FDA announced that it is working to streamline a process that will bring more products to consumers — while meeting standards for safety, quality and labeling
May 16: Abbott and FDA reach agreement to reopen Michigan baby formula facility.
However, the FDA has not yet released a time frame for allowing the facility to resume production.
The FDA also implemented new measures, effective for 180 days, to increase imports of baby formula manufactured abroad.
May 18: Biden invoked the Defense Production Act to increase production of baby formula and issued a directive for planes to bring in supplies from overseas, following mounting pressure from Congress.
June 1: In response to questions from reporters, Biden admits he was not told about the formula shortage until April.
June 3: White House press secretary Karine Jean-Pierre is being grilled by reporters about who told the president about the shortage, when he was told and the process used to determine when the information reaches the presidential level.
She avoided further questions on the subject and would not provide any details.
“There is no specific person I can call you. But that is the usual way we proceed through the usual channels. I don’t have a specific person. But that’s how it goes with any problem, not just this one. It goes through normal channels, and senior White House staff usually brief him on various matters, she said.
June 4: Abbott restarts production at Michigan plant.
The facility is prioritizing production of specialty and metabolic formulas first, with consumers expected to see these products on store shelves around June 20.
Abbott will then resume production of all other formulas, and the facility has previously said it will take six to eight weeks for stores to be replenished.
June 12: Abbott is halting production at its Sturgis, Michigan plant for the second time since February.
The facility was closed due to severe thunderstorms and heavy rain that swept through southwest Michigan, causing parts of the building to flood.
Abbott said in a statement that it needs to assess the damage and rehabilitate the factory, but did not indicate how much damage the factory suffered.
Production for its EleCare specialty formula has been suspended, but the company insisted there is enough supply to meet demand until production restarts.
The company did not give a time frame in its statement for when production will resume.
June 22: The FDA launched a new investigation after another child died after allegedly consuming infant formula manufactured by Abbott Laboratories.
The most recent infant death occurred in January, according to a consumer complaint submitted to the FDA on June 10.
An Abbott spokesperson told DailyMail.com on June 22 that the company was informed of the infant death case last week. However, the formula maker claims there was “limited product and clinical information provided to evaluate the case.”
“At this time, there are no conclusions to be drawn and no evidence to suggest a causal link between Abbott’s formulas and this reported case,” the spokesperson said. “If further information is available, we will investigate further in accordance with our complaints handling process.”
The FDA also disclosed 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 1st: Production of EleCare, a specialty formula for infants with severe food allergies and digestive problems, has resumed at the Abbott Nutrition plant in Michigan.
Abbott officials said the facility is working to restart production of Similac, another popular formula product, “as soon as we can.”
August 26: Abbot announces it will restart Similac infant formula at its Sturgis, Michigan facility.
