TIMELINE SHOWS HOW AMERICA’S LARGEST BABY FORMULA FACTORY STOPPED PRODUCTION
Abbott Laboratories, the largest baby food supplier in the US, stopped production at its Michigan plant in February 2022 due to reports of deadly bacterial infections.
A timeline of events shows that the closure was that the plant was previously under the supervision of the US Food and Drug Administration (FDA).
September 2021: The FDA conducted a four-day inspection of the Abbott Laboratories plant in Sturgis, Michigan.
The inspection report found that the factory “failed to maintain clean and hygienic conditions” in at least one building where baby food was produced, processed, packaged or stored.
FDA officials also found poor handwashing among Abbott factory workers who “worked directly with infant formula.”
The FDA also noted a 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 plant.
The document, which was made public in April 2022 by Congresswoman Rosa DeLauro, was written by a former factory employee.
Among other things, the employee accused the factory of lax cleaning practices, falsifying records, releasing untested infant formula and concealing information during a 2019 FDA audit.
January – March 2022: The FDA conducted multiple inspections of the Sturgis plant over the course of three months in 2022. A ten-page inspection report revealed multiple violations at the facility.
The agency alleged that the factory failed to ensure that all surfaces that come into contact with infant formula were maintained to prevent cross-contamination.
The report says the facility “has not established a system of process controls” to ensure that the infant formula is “not adulterated by the presence of microorganisms in the formula or processing environment.”
Officials also claimed that the plant failed to disclose in an investigative report whether a health hazard existed at the facility.
In addition, the report noted that factory workers were not wearing the “necessary protective equipment” when working directly with infant formula.
February 17: US health officials are urgently warning parents against the use of three popular baby foods manufactured at the Abbott plant in Michigan. Researchers claim the products were recently linked to bacterial contamination after a baby died and three others fell ill.
Abbott voluntarily recalled several major brands and closed its Sturgis plant.
The FDA also said it is investigating four reports of babies hospitalized after consuming formula, including one who died.
February 28: Abbott Laboratories expanded its Similac infant formula recall after a second infant died exposed to the powdered infant formula.
15 of April: Abbott is releasing a statement claiming it is working closely with the FDA to restart operations at the Sturgis plant.
Week of April 24: The national share of sold-out baby food reached 40 percent. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly the hardest hit by the shortages, reported about 50 percent out of stock.
May 10th: Abbott is issuing a statement to DailyMail.com claiming “thorough investigation” by the FDA and Abbott revealed that “infant formula produced at our Sturgis facility is not the likely source of infection in the reported cases and that there was no outbreak caused by products from the facility’.
Abbott claims they are “working closely with the FDA to resume operations at the plant,” with the spokesperson noting, “We continue to make progress on corrective actions and will take additional actions as we work to address items related to the recent recall’.
The FDA told DailyMail.com it was in talks with “Abbott and other manufacturers to increase production of various specialty and metabolic products,” but declined to say when the Sturgis plant could reopen.
Senator Mitt Romney sent a letter to the FDA and the United States Department of Agriculture (USDA) urging leaders to address the bottle-feeding shortage and work to prevent future threats to infant health.
11 May: Lawmakers on Capitol Hill are announcing plans to hold a hearing on infant formula shortages in two weeks.
Abbott announced it would take up to 10 weeks to get baby food to retailers once the Sturgis factory reopens.
Abbott also said, “After a thorough review of all available data, there is no evidence to link our formulas to these teething problems.”
May 12th: Jen Psaki, White House Press Secretary, 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.
13 May: Addressing the formula crisis at a press briefing, Biden said, “We’ll have significantly more formula on the shelves in a few weeks.”
The FDA announced it is working to streamline a process that helps more products reach consumers – while also meeting safety, quality and labeling standards
May 16: Abbott and FDA agree to reopen Michigan baby food plant.
However, the FDA has yet to announce a timetable for the plant to resume production.
The FDA has also introduced new measures, effective for 180 days, to increase imports of foreign-produced baby foods.
May 18: Biden invoked the Defense Production Act to boost baby food production and issued a directive for planes to bring in supplies from abroad after mounting pressure from Congress.
1 June: Responding to questions from reporters, Biden admits he was not made aware of the formula shortage until April.
June 3: White House Press Secretary Karine Jean-Pierre is being questioned by reporters about who told the president about the deficit, when he was told, and the process used to determine when information reaches the presidential level.
She evaded multiple questions on the subject and declined to provide details.
“There is no specific person I can call to you. But it is the normal way we proceed through the regular channels. I don’t have a specific person. But that’s the way it is with every issue, not just this one. It goes through regular channels and senior White House staff usually brief him on various issues,” she said.
June 4: Abbott is restarting production at its Michigan plant.
The factory is prioritizing the production of specialty and metabolic formulas primarily, with consumers expecting these products to hit store shelves around June 20.
Abbott will then resume production of all other formulas, with the factory previously saying it will take six to eight weeks to replenish stocks in stores.
12 June: Abbott halts production at its Sturgis, Michigan plant for the second time since February.
The plant was closed due to severe thunderstorms and heavy rains moving through southwestern Michigan, flooding parts of the building.
Abbott said in a statement it must assess the damage and re-decontaminate the plant, but did not specify how much damage the plant 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 offer a timeline for when production will resume in its statement.
June 22: The FDA launched a new investigation after another child died after allegedly consuming infant formula produced by Abbott Laboratories.
The last infant death occurred in January, according to a consumer complaint sent to the FDA on June 10.
An Abbott spokesperson told DailyMail.com on June 22 that the company was made aware of the infant deaths last week. However, the formula’s manufacturer claims that “limited product and clinical information has been provided to evaluate the case.”
“At this time, there are no conclusions to be drawn and no evidence of a causal relationship between Abbott’s formulas and this reported case,” the spokesperson said. “If additional information becomes available, we will investigate further in accordance with our complaint handling process.”
The FDA also revealed 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 special formula for infants with severe food allergies and digestive problems, has resumed at Abbott Nutrition’s Michigan plant.
Abbott officials said the plant is working to resume production of Similac, another popular formula product, “as soon as possible.”
August 26: Abbot announces it will restart the Similac infant formula product at its Sturgis, Michigan, plant.
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