Abbot baby formula factory closes for the second time in four months as heavy flooding hits the building

Abbott Laboratories, the largest supplier of baby formula in the US, stopped production at its factory in Michigan in February 2022 amid reports of fatal bacterial infections.

A timeline of events shows that it was concluded that the plant had previously been under control by the US Food and Drug Administration (FDA).

September 2021: The FDA conducted a four-day inspection of the Abbott Laboratories plant in Sturgis, Michigan.

De inspection report disclose the plant ‘not maintaining’ clean and sanitary conditions in at least one building that produced, processed, packaged or kept baby formula.

FDA officials also observed poor hand washing among Abbott plant personnel who “worked directly with milk formula.”

The FDA also noted an instance of improper equipment maintenance and temperature control.

October 2021: A whistleblower sends the FDA a 34-page document outlining potential concerns with the Sturgis plant.

The document, which was made public by Congresswoman Rosa DeLauro in April 2022, was written by a former plant employee.

The employee accused the plant of lax cleaning practices, falsifying records, releasing untested child formula and hiding information during an FDA inspection in 2019, among other issues.

January – March 2022: Over the course of three months in 2022, the FDA conducted multiple inspections at the Sturgis plant. ten page inspection report disclose multiple violations at the facility.

The agency claimed that the plant failed to ensure that all surfaces that came in contact with baby formula were maintained to prevent cross-contamination.

The report states that the facility ‘did not set up a system of process controls’ to ensure that the baby formula ‘is not processed due to the presence of microorganisms in the formula or the processing environment.’

Officials also claimed that the plant had not disclosed in an investigation report whether there was a health hazard at the facility.

In addition, the report said plant workers did not wear the ‘necessary protective material’ when working directly with baby formula.

February 17: U.S. health officials are urging parents to use three popular baby formulas produced at the Abbott plant in Michigan. Researchers claim that the products were recently linked to bacterial infection after one baby died and three others became ill.

Abbott voluntarily recalled several major brands and closed its Sturgis factory.

The FDA also said it is investigating four reports of toddlers being hospitalized after consuming the formula, including one who died.

February 28: Abbott Laboratories expanded its recall of Similac baby formulas after a second baby exposed to the powdered baby formula died.

April 15: Abbott gives a statement claim that it is working closely with the FDA to resume operations at the Sturgis plant.

Week of April 24th: The national share of unprepared baby formula hit 40 percent. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, apparently hit hardest by the deficits, reported supplies out of the stock of about 50 percent.

May 10: Abbott publishes a statement to claiming that ‘in-depth investigation’ by the FDA and Abbott revealed that ‘baby products produced at our Sturgis facility are not the likely source of infection in the reported cases and that there no outbreak was caused by ‘facility’ products.

Abbott claims that they are ‘working closely with the FDA to restart operations’ at the plant, noting the spokesperson:’ We will continue to make progress on corrective actions and will implement additional actions as we work on addressing items related to the recent recall ‘.

The FDA told that 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 plant could reopen.

Sen. Mitt Romney issued a letter to the FDA and U.S. Department of Agriculture (USDA) urging leaders to address the shortage of formulas and work to prevent future threats to child health.

May 11: Lawmakers on Capitol Hill announce plans to hold a hearing in two weeks on shortages of milk formulas.

Abbott announced it would take a maximum of ten weeks for the company to get baby formula from retailers when the Sturgis factory reopens.

Abbott also said: “After an in-depth review of all available data, there is no evidence to link our formulas to these childhood diseases.”

May 12: White House Press Secretary Jen Psaki defends the government’s closure of the Abbott plant.

President Joe Biden met with executives from manufacturers and retailers for baby formula to address the shortage.

May 13: Biden addresses the formula crisis during a press briefing, saying, ‘We’ll get 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 get more products to consumers – while also meeting safety, quality and labeling standards

May 16: Abbott and the FDA reach agreement to reopen baby formula facility in Michigan.

However, the FDA has yet to disclose a time frame to allow the plant to resume production.

The FDA has also introduced new measures, in effect for 180 days, to increase the import of baby formula produced abroad.

May 18: Biden called for the Defense Production Act to stimulate baby formula production and issued guidelines for aircraft to bring in supplies from abroad, following increasing pressure from Congress.

June 1st: In response to reporters’ questions, Biden admits he was not told about the lack of formulas until April.

June 3: White House Press Secretary Karine Jean-Pierre is being grilled 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 avoided multiple questions on the subject and would not give specifics.

‘There is no specific person I can call you. But it’s the regular way we move forward through the regular channels. I do not have a specific person. But that’s how it is about every problem, not just this one. It goes through regular channels, and senior White House staff usually bring him informed about various issues, ‘she said.

June 4: Abbott resumes production at his Michigan plant.

The plant is prioritizing the production of specialty and metabolic formulas for the first time, with consumers expected to see these products on store shelves around June 20th.

Abbott will then resume production of all other formulas, with the plant having previously said it will take six to eight weeks before supplies are replenished at stores.

Abbot baby formula factory closes for the second time in four months as heavy flooding hits the building

Source link Abbot baby formula factory closes for the second time in four months as heavy flooding hits the building

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