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A former Abbott Nutrition employee filed a whistleblower complaint with the U.S. Department of Labor’s Occupational Safety and Health Administration in February 2021 about the company’s Sturgis, Michigan, plant, months before the case was previously known. A source familiar with the matter told CNN on Wednesday.
The source said the complaint was filed on February 16, 2021 and was forwarded to Abbott and the US Food and Drug Administration three days later.
The Wall Street Journal first reported the news on Wednesday, which also said the whistleblower was terminated in August 2020 and filed a discrimination complaint with Michigan OSHA shortly thereafter.
The Journal said Abbott submitted a formal response to the February complaint in April 2021, according to the documents and an unnamed source. The Journal reported that the whistleblower filed a complaint with the FDA in October 2021, which expanded on the safety claims made in the February complaint.
October 2021 complaint was Released at the end of April by US Representative Rosa DeLauro, who described its allegations as “extremely disturbing”.
Abbott said Wednesday that 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 inspected the Sturgis facility “for cause” between January and March 2022. Also, the FDA was learning about four dangerous Chronobacter infections in babies who had ingested it. Formula, and Abbott recalled three of its popular Formula products.
While the inspection was underway, Abbott closed the facility to address problems identified by the FDA. The recalls and closures disrupted an industry already grappling with supply chain problems, leading to formula shortages across the country.
In April, Abbott submitted a corrective action plan to the FDA, and they entered into a consent decree regarding the plant’s reopening in May. The Sturgis facility resumed production of infant formula on Saturday.
The company said Wednesday, “Abbott takes employee concerns very seriously and we promote a culture of compliance to produce the best and highest quality products. … We believe this was a former employee.” Which was sacked for serious violations of Abbott’s food security policies.
“While at the company, the former employee did not bring forward product safety complaints to our Office of Ethics and Compliance. Following the August 2020 dismissal, the former employee brought forward a product safety complaint to Michigan OSHA in October 2020. He The complaint was dismissed. The federal OSHA complaint from February 2021 was a new complaint that raised new and different topics. And it continued a pattern of ever-evolving, ever-increasing allegations. We investigated the federal OSHA complaint and made the allegations. Couldn’t confirm.”
DeLauro said Wednesday’s news was “cursive”.
“We must get to the bottom of who knew what and when, and we won’t be able to do that if everyone involved wants to avoid accountability,” she said.
An FDA spokeswoman acknowledged the questions surrounding the timeline on Wednesday, but said, “Our top priority right now is addressing the dire need for infant formula in the U.S. market, and our team is working overnight to help meet it.” -Day working – including ensuring Abbott takes appropriate corrective action to address the unsanitary conditions observed by the FDA.”