FDA reveals dire 'unsanitary' conditions at baby formula plant linked to shortages, including broken equipment

• An Abbott Nutrition baby formula plant had "egregiously unsanitary" conditions, the FDA said.
• FDA commissioner Robert Califf said a leaky roof and water pooling was found at the factory.

A baby food plant linked to product recalls and formula shortages across the US had a leaky roof, broken equipment, condensation, and unsanitary surfaces, according to the Food and Drug Administration.

FDA commissioner Robert Califf said conditions at Abbott Nutrition's plant in Sturgis, Michigan, were "egregiously unsanitary" and allowed bacteria to spread.

"Frankly, the inspection results were shocking," he told the House Subcommittee on Energy and Commerce on Wednesday, also citing insufficient hand-washing by staff and water pooling at the plant.

The Abbott Nutrition plant was shut down in February following complaints of illness in infants who consumed the products manufactured there, two of whom later died. The illnesses were linked to the environmental bacteria, cronobacter sakazakii.

The FDA could not link the infections in the infants directly to the plant, but the agency said stated the situation was a "highly unusual combination of events."

Califf said the FDA could not rule out the link between the infections and the unsanitary conditions at the plant.

Christopher Calamari, Abbott Nutrition's senior vice-president, said the company was "deeply sorry."

"To all of the families who depend on us for a reliable supply of formula — we let you down," he said in written testimony.

Recalls of formula produced at the plant have contributed to nationwide shortages and left parents grappling to secure supplies.

Calamari said production at the plant was expected to resume in early June, but it would take a further six to eight weeks for products to reach the shelves. Abbott was making improvements to the factory, including adding more easily cleanable flooring, he said.

Califf also admitted to internal issues within the FDA that delayed an investigation after a whistleblower complaint was sent to several officials in October 2021 but no action was taken immediately.

The FDA and Abbott Nutrition did not immediately respond to Insider's requests for comment.