The FDA inspects the Sturgis plant and finds Abbott did not test enough samples of infant formula before distribution.

The FDA receives a report from the Minnesota Department of Health that an infant was hospitalized with Cronobacter sakazakii after having consumed formula produced in the plant. The agency immediately reports the case to Abbott, and no Cronobacter is detected after testing product from the plant.

The FDA completes a four-day routine inspection of the Sturgis plant.

A report found instances of standing water and noted that personnel working directly with infant formula did not thoroughly wash their hands. The facility "did not maintain a building used in the manufacturing, processing, packing or holding of infant formula in a clean and sanitary condition," the report said.

A 34-page whistleblower complaint is sent to the FDA outlining a lack of internal controls and instances of employees falsifying records and releasing untested product for distribution.

The report also notes problems associated with the traceability of products and that active efforts were undertaken during the 2019 inspection to keep FDA auditors from "learning of certain events believed to be associated with the discovery of micros in infant formula at the Sturgis site."

The complaint is reviewed by multiple staff members, though a hard copy of the report is not sent to leadership "due to an isolated failure in FDA’s mailroom," according to the agency's testimony. 

The FDA receives a second report of Cronobacter sakazakii after an infant died potentially after consuming formula produced at the plant. The agency again contacts Abbott and does not find any positive samples of the bacterium in samples from the plant.

The FDA informs Abbott it will conduct a for-cause inspection of the Sturgis plant in early January 2022. The company responds by asking for a delay after approximately a dozen plant employees test positive for COVID-19.

The FDA receives a third Cronobacter report related to an infant in Texas who was hospitalized after ingesting formula produced at the Sturgis facility. Tested product from the plant again finds no positive samples.

FDA begins its for-cause inspection of the plant. The inspection was delayed after a rise in COVID-19 infections among Abbott employees.

Seven of the FDA's environmental samples taken from the plant suggest the potential presence of Cronobacter.

The agency meets with the U.S. Department of Agriculture's Special Supplemental Nutrition Program for Women, Infants, and Children to discuss the potential for supply chain issues from a recall.

FDA sequences six confirmed samples of Cronobacter from the Sturgis plant collected during the recent inspection. 

FDA leadership–including then-Acting Commissioner Janet Woodcock–receive a copy of the whistleblower complaint via email following mailroom delays at the agency.

The FDA recommends Abbott issue a voluntary recall. The same day, Abbott ceases production at the Sturgis plant.

Abbott, which does not have a mitigation plan to produce speciality metabolic formulas at one of its other facilities, agrees to hold certain products produced at Sturgis "given the critical access need."

The FDA again asks Abbott to issue a voluntary recall, which has yet to occur. The FDA informs government partners and the American Academy of Pediatrics of the supply chain impacts from the closure of the Sturgis plant, which is a major infant formula supplier and one of the largest producers of formula for children with metabolic conditions.

Abbott announces a voluntary recall following a third recommendation from the FDA. 

The FDA receives a report of a fourth Cronobacter case. An infant in Ohio died after ingesting formula from Abbott's plant in Sturgis, marking the second reported death in the crisis.

A report finds more instances of standing water and concludes the company did not establish process controls "to ensure that infant formula does not become adultered."

The FDA tells Abbott it won't object to the release of specialized formula meant for children with metabolic conditions after enhanced finished product testing. The agency also allows the company to release product on a case-by-case basis in instances of "urgent need."

President Joe Biden meets with retailers and manufacturers including Walmart, Target, Reckitt and Gerber to discuss ways to boost production and the availability of infant formula.

"We absolutely recognize the frustration of parents and families," a senior administration official says on a press call. "That’s why we are announcing this package of actions today to speed things up."

The FDA and Abbott Nutrition sign a proposed consent decree, approved by the U.S. District Court for the Western District of Michigan. 

The decree requires Abbott to retain an independent expert at the plant to review operations and ensure compliance.The company must also implement a sanitation plan, an environmental monitoring plan and employee training programs, according to an FDA release. 

The same day, the FDA announces it will temporarily ease requirements for formula manufacturers on a case-by-case basis until Nov. 14 to boost domestic production and encourage more imports. 

Biden invokes the Defense Production Act requiring suppliers to prioritize orders from formula makers over other customers. 

The president also announces Operation Fly Formula, which will use Department of Defense aircraft to speed the delivery of formula imports.

U.K.-based Kendal Nutricare estimates it will export 2 million cans of infant formula to the United States by the beginning of June.

Abbott says it aims to reopen the Sturgis plant the first week of June at a federal hearing investigating the infant formula shortage. 

Christopher Calamari, who leads Abbott's North America nutrition division, said the company has been importing formula from its facility in Ireland. By the end of June, the company expects to supply more formula "than we did in January before the recall." 

"We are deeply, deeply sorry," Calamari told the oversight subcommittee within the House Committee on Energy and Commerce. "And we are committed to ensuring that this never happens again." 

Danone's Nutricia business in the U.K. says it will provide about 500,000 additional cans of specialized medical formula to help ease the crisis. 

Bubs Australia agrees to provide at least 1.25 million cans of infant formula under the FDA's streamlined process to facilitate imports.