CNN —
A former employee of Abbott Nutrition documented his concerns that the company was hiding safety problems at its Sturgis, Mich., production facility and sent a detailed complaint to the US Food and Drug Administration months before infant formula was removed from grocery store shelves.
The complaint was released Thursday 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.”
Abbott recalled three popular brands of powdered infant formula in February after reports that four infants drinking formula manufactured at the facility had fallen ill with rare and serious infections caused by Cronobacter sakazakii bacteria. Two of the babies died. Production at the facility was halted and remains paused.
In an April 15 statement posted to the company’s website, Abbott said it was working closely with the FDA to restart operations at the plant.
The former employee, who worked at Abbott Laboratories’ Sturgis site, stated that he saw records falsified “on multiple occasions,” and in most situations, information was not disclosed when it should have been.
For instance, according to the complaint, the employee reported observing events that were understated or inaccurately described “to limit or avoid oversight” and then “failing to maintain accurate maintenance records.”
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