(CNN) — A former Abbott Nutrition employee filed a whistleblower complaint about the Sturgis, Michigan plant with the U.S. Department of Labor’s Occupational Safety and Health Administration in February 2021, a source familiar with the report said. case to CNN Wednesday.
The complaint was filed on Feb. 16, 2021 and was passed on to Abbott and the U.S. Food and Drug Administration three days later, the source said.
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The news was first reported Wednesday by the Wall Street Journal, which also said the whistleblower was terminated in August 2020 and filed a discrimination complaint with Michigan OSHA shortly after.
According to documents and an unnamed source, Abbott filed a formal response to the February complaint in April 2021. The whistleblower then filed a complaint with the FDA in October 2021, expanding the safety claims in the February complaint, the Journal reported.
The October 2021 complaint was released in late April by US Representative Rosa DeLauro, who called the allegations “extremely disturbing.”
Abbott said on Wednesday it was not aware of that complaint until its release in April, “and there is an open investigation into these allegations.”
The FDA interviewed the whistleblower in December 2021, and FDA inspectors conducted personal inspections of the Sturgis facility between January and March 2022. At the same time, the FDA learned of four dangerous Cronobacter infections in infants who had consumed formula, and Abbott recalled three of its popular formula products.
While the inspection was underway, Abbott closed the facility to address issues identified by the FDA. The recalls and closures hampered an industry already hampered by supply chain problems, contributing to a nationwide formula shortage.
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In April, Abbott filed a corrective action plan with the FDA, and they reached an approval decision regarding the factory’s reopening in May. The Sturgis factory resumed infant formula production on Saturday.
The company said on Wednesday, “Abbott takes employee concerns very seriously and we foster a culture of compliance to produce the best and highest quality products. … We believe this is a former employee who was fired for serious violations of Abbott’s food safety policies.
“While with the company, the former employee did not file any product safety complaints with our Office of Ethics and Compliance. After being fired in August 2020, the former employee filed a complaint with Michigan OSHA in October 2020 that was unrelated to product safety. That complaint was rejected. The February 2021 OSHA federal complaint was a new complaint that raised new and different issues. And it continued a pattern of ever-evolving, ever-escalating accusations. We have investigated the federal OSHA complaint and have been unable to confirm the allegations.”
DeLauro said Wednesday’s news is “devastating.”
“We need to get to the bottom of who knew what and when, and we won’t be able to do that if everyone involved wants to evade responsibility,” she said.
An FDA spokesperson acknowledged questions surrounding the timeline Wednesday, but said: “Our top priority right now is to address the urgent need for infant formula in the U.S. market, and our teams are working day and night to make that happen — including ensure that Abbott takes appropriate corrective action to address unsanitary conditions observed by the FDA.”
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