Whistleblower Alerted FDA to Product Safety at Baby Formula Plant Months Before Recall

The Food and Drug Administration (FDA) was provided a confidential whistleblower complaint by a former employee who worked in the production plant in Quality Systems, a subunit of the Quality Assurance organization in Sturgis, MI, as part of Abbott’s Nutritional Division. The document detailed product safety issues at a plant that manufactured infant formula linked to a deadly, ongoing outbreak of cronobacter among babies.

The complaint was just released by Rep. Rosa DeLauro, D-Connecticut, the chair of the House Appropriations Committee. The congresswoman said she had received the complaint this week and called its allegations “extremely disturbing.” According to new reports, the document was submitted to the FDA on October 20, 2021. The FDA did not interview the whistleblower until late December 2021.  The FDA did not inspect the plant in person until January 31, 2022, and the recall was not issued until February 17, 2022. Read more about the complaint and Rep. DeLauro’s response here.

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