Thursday 2 June 2022 07:19 PM Biden administration launches an audit of the FDA's actions on Abbott plant ... trends now

Abbott Laboratories, the biggest baby formula supplier in the U.S., ceased production at its Michigan plant in February 2022 amid reports of fatal bacterial infections.

A timeline of events shows reveals the shut down was the plant had previously been under scrutiny by the U.S. 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 revealed the plant 'did not 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 Abbott plant staff who 'worked directly with infant 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 infant formula, and hiding information during an FDA audit in 2019, among other issues. 

January - March 2022: The FDA conducted multiple inspections at 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 the plant failed to ensure that all surfaces that contact infant formula were maintained to prevent cross-contamination.

The report states the facility 'did not establish a system of process controls' to ensure the baby formula 'does not become adulterated due to the presence of microorganisms in the formula or the processing environment.'

Officials also alleged the plant failed to disclose in an investigation report whether a health hazard existed at the facility.

Additionally, the report stated plant workers were did not wear the 'necessary protective material' when working directly with infant formula.

February 17: U.S. health officials urgently warn parents against using three popular baby formulas manufactured at the Abbott plant in Michigan. Investigators claim the products were recently linked to bacterial contamination after an infant died and three others fell ill.

Abbott voluntarily recalled several major brands and shut down 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 formulas after a second infant who was exposed to the powdered baby formula died.

April 15: Abbott releases a statement alleging it is working closely with the FDA to restart operations at the Sturgis plant. 

Week of April 24: The nationwide share of out-of-stock baby formula hit 40 percent. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates 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 there was not an outbreak caused by products from the facility'.

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

The FDA told DailyMail.com it was holding discussions with 'Abbott and other manufacturers to increase production of different specialty and metabolic products' but refused 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 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 it would take up to ten weeks for the company to get baby formula to retailers once the Sturgis plant reopens.

Abbott also said: 'After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.'

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

President Joe Biden met with executives from infant formula manufactures and retailers to address the shortage.

May 13: Biden addresses the formula crisis during a press briefing, saying: 'We're going to be, in a matter of weeks or less, getting significantly more formula on shelves.' 

The FDA announced it was 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 timeframe for allowing the plant to resume production. 

The FDA also implemented new measures, in effect for 180 days, to increase imports of baby formula produced overseas.

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 growing pressure from Congress.