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Tuesday, April 7, 2026

Whistleblower warned FDA about formula plant months before baby deaths - POLITICO

Shelves are shown almost empty of baby formula with signs warning customers that they are limited to eight cans per customer. | Christopher Pearce/Getty Images

By Helena Bottemiller Evich

04/28/2022 11:24 AM EDT

A former employee at Abbott Nutrition’s Sturgis, Mich., infant formula plant flagged concerns about food safety violations directly with senior FDA officials in October — months before two infants died and another was hospitalized from bacterial infections after ingesting formula made at the plant, according to a document reviewed by POLITICO.

In a 34-page document sent to officials Oct. 19 and 20, the whistleblower outlined allegations of lax cleaning practices, purposely falsified records and efforts by plant officials to keep FDA from learning about serious issues related to the plant’s own system for checking for bacteria in formula, among other things. The warning came weeks after health officials in Minnesota had already reported to both FDA and CDC that an infant in the state had been hospitalized for Cronobacter sakazakii — a rare but deadly bacteria — after consuming formula from the same plant.

Have you complained to the FDA about the Similac recall or another infant formula problem? We want to hear from you.

Hard copies of the disclosure were sent via FedEx to senior food safety officials and other leaders at FDA. They included FDA’s top official, then-acting Commissioner Janet Woodcock, Susan Mayne, director of the Center for Food Safety and Applied...



Read Full Story: https://www.politico.com/news/2022/04/28/whistleblower-fda-baby-formula-00028569