Abbott baby formula: Former employee filed whistleblower complaint over Sturgis facility eight months before known date


The complaint was filed on Feb. 16, 2021, and was forwarded to Abbott and the U.S. Food and Drug Administration three days later, the source said.

The news was first reported on Wednesday by The Wall Street Journal, which also said the whistleblower was fired in August 2020 and filed a discrimination complaint with Michigan OSHA shortly thereafter.

Abbott submitted a formal response to the February complaint in April 2021, according to documents and an unnamed source, the Journal said. The whistleblower then filed a complaint with the FDA in October 2021 that expanded on the safety claims made in the February complaint, the Journal reported.

The October 2021 complaint was released in late April by U.S. Representative Rosa DeLauro, who called her allegations « extremely disturbing. »

Abbott said Wednesday he was unaware of the complaint until it was released in April, « and there is an ongoing investigation into these allegations. »

The FDA interviewed the whistleblower in December 2021, and FDA inspectors conducted in-person « cause » inspections of the Sturgis facility between January and March 2022. At the same time, the FDA learned of four dangerous infections from Cronobacter in infants who had consumed formula, and Abbott recalled three of its popular formula products.

While the inspection was ongoing, Abbott shut down the facility to address issues identified by the FDA. The recalls and shutdown have hampered an industry already hampered by supply chain issues, contributing to a nationwide formula shortage.

In April, Abbott submitted a corrective action plan to the FDA, and they entered into a consent decree regarding the reopening of the plant in May. The Sturgis plant resumed production of infant formula on Saturday.

The company said Wednesday, « Abbott takes employee concerns very seriously and we foster a culture of compliance to produce the best, highest quality products. … We believe this is a former employee who has was terminated due to serious violations of Abbott’s food safety policies.

« While at the company, the former employee did not file a product safety complaint with our Ethics and Compliance Office. After being terminated in August 2020, the former employee filed a complaint with Michigan OSHA in October 2020 unrelated to product safety. This complaint was dismissed. The February 2021 federal complaint against OSHA was a new complaint that raised new and different issues. And she continued an ever-changing and escalating pattern of allegations. We investigated the federal complaint against OSHA and were unable to confirm the allegations. »

DeLauro said Wednesday’s news was « overwhelming. »

« We need to find out who knew what and when, and we can’t do that if everyone involved wants to sidestep accountability, » she said.

An FDA spokesperson acknowledged issues surrounding the timing on Wednesday, but said, « Our top priority right now is to meet the urgent need for infant formula in the U.S. market, and our teams are working night and day to help achieve this, including ensuring that Abbott takes appropriate corrective action to address unsanitary conditions observed by the FDA. »

CNN’s Amanda Sealy and Carma Hassan contributed to this report.

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