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In October 2021, just months before Abbott Nutrition initiated a recall of infant formula tainted with the dangerous bacteria Cronobacter sakazakii, a whistleblower from the Michigan facility that produced the formula raised serious concerns regarding food safety practices to the FDA. Unfortunately, these warnings went unheeded. A review by Politico revealed a detailed 34-page document sent by the whistleblower to key FDA officials, including then-acting Commissioner Janet Woodcock and other senior food safety officials.
The whistleblower highlighted critical safety issues, particularly concerning inadequate sanitation protocols and allegations that management falsified records related to bacterial testing of their products. One alarming issue pointed out was the plant’s persistent failure to ensure that the powdered formula cans were properly sealed, which risked contaminating the product. Instead of addressing this major safety concern, the whistleblower claimed that employees were testing empty cans for bacteria rather than those filled with powdered formula, a practice he believed was still ongoing and not disclosed to the FDA.
Following his repeated attempts to raise these concerns, the whistleblower was ultimately terminated, and his case is currently under investigation by OSHA. His document stated that “as long as one was not inclined to ‘rock the boat,’ lax practices, including regulatory violations, were consistently overlooked.”
Before the whistleblower’s report, the FDA had already been alerted to cases of infants falling ill from the rare bacteria. In September 2021, the agency received a report of an infant’s illness related to this bacteria. Coincidentally, the FDA inspected the plant that same week but reported no bacterial evidence. Tragically, by the time the FDA began a deeper investigation into the ongoing contamination cases, two infants had already died. The subsequent recall, coupled with ongoing supply chain issues, has contributed to a significant shortage of baby formula worldwide. For information about potentially affected formula, you can visit www.similacrecall.com.
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Summary:
A whistleblower from an infant formula plant alerted the FDA to serious sanitation issues and falsified records months before a recall linked to two infant deaths. Despite previous reports of infant illnesses, the FDA’s inspection found no contamination. The whistleblower’s concerns were ignored, leading to tragic consequences and a global baby formula shortage.
Keyphrase: baby formula safety concerns
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