FDA reveals details of ‘egregiously unsanitary’ conditions at baby formula plant that led to shutdown

The Food and Drug Administration revealed details this week about what it calls “egregiously unsanitary” conditions at a baby formula plant in Sturgis, Michigan that led to the plant being shut down and contributed to the US baby formula shortage.

In a hearing in front of the Subcommittee on Energy and Commerce on Wednesday, FDA commissioner Robert Califf described the conditions found at the Abbott Nutrition formula plant in February, including “leaky roof, broken equipment, condensation, and unsanitary surfaces.”

The plant was inspected after infants who consumed the products manufactured there began falling ill, and two died. The infections were later linked to cronobacter sakazakii, an environmental bacteria.

While Califf said the FDA could not conclusively link the infections to the Sturgis plant, the “shocking” results of the inspection were too coincidental to rule out that the plant’s conditions were related. Califf explained the FDA’s findings that employees at the plant engaged in improper handwashing practices. In addition, Califf described a leaky roof that had resulted in pooling water on the floor, which caused condensation and possibly contaminated the products.

Senior Vice President for Abbott, Robert Calamari, apologized to consumers in written testimony, saying, “To all of the families who depend on us for a reliable supply of formula — we let you down,” and saying he was “deeply sorry.” Calamari also said production at the Sturgis plant was slated to restart in six to eight weeks, pending the plant passes FDA inspections and has rectified the offending conditions.

Califf also revealed that a whistleblower complaint late last year was not acted upon at the time, and that internal issues at the FDA had delayed the inspection and investigation of the Sturgis formula plant. The resulting shortage of infant formula has left parents across the country scrambling to find the nutrition they need to feed their babies in the last several weeks.