A Whistleblower Alerted FDA to Contaminated Baby Formula Linked to Two Infant Deaths

A former employee at a Michigan baby formula plant raised alarms about food safety violations to the FDA months prior to the deaths of two infants, but his concerns went unheeded. In a document reviewed by Politico, the whistleblower detailed unsanitary practices and alleged that the plant’s management falsified records regarding bacterial testing procedures.

Whistleblower’s Concerns Ignored

On October 19, 2021, this whistleblower reached out to senior officials at the FDA, including then-acting Commissioner Janet Woodcock, but received no response. Among the alarming issues highlighted was the failure to ensure that powdered formula cans were properly sealed, which could compromise product safety. Rather than addressing this critical problem, employees were reportedly testing empty cans for bacteria, an action the whistleblower claimed was not documented in any records.

The whistleblower stated that he was dismissed from his position after repeatedly voicing these safety concerns, and his case is currently under investigation by OSHA. The document he submitted noted a culture of overlooking regulatory violations as long as employees did not “rock the boat.”

Previous Cases of Contamination

Before the whistleblower’s report, there had already been cases of infants falling ill from the bacteria Cronobacter sakazakii. In September 2021, the FDA received news of an infant who was infected, prompting an inspection of the plant. However, no contamination was found at that time. It wasn’t until after the two tragic infant deaths that the FDA began to actively investigate the ongoing bacterial contamination cases, which contributed to a significant formula shortage worldwide.

Further Information

For more information on whether your purchased formula is affected by the recall, visit www.similacrecall.com.

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Summary

A whistleblower at a Michigan baby formula plant alerted the FDA about serious food safety violations months before two infant deaths occurred due to contaminated formula. Despite raising these concerns, his warnings were ignored, leading to tragic consequences and a global formula shortage.