Abbott Nutrition’s plant in Sturgis, MI, where Similac and other baby formulas are made, has been idle for three months but may soon be resuming production. The temporary stoppage has exacerbated a nationwide shortage of infant formula due to pandemic-related supply chain issues.
Production at the facility was halted in February after the U.S. Food and Drug Administration (FDA) found a number of food safety violations there during its investigation of Cronobacter illnesses and deaths among infants who consumed Similac.
In March, the FDA released documents from its most recent inspections at the plant. These documents show that FDA inspectors found Cronobacter strains at the plant, that Abbott did not retain a sample of the lot Similac Pro Total Comfort associated with a fatal illness, and did not include a determination of root causes of contamination. The reports also show that between January 1, 2020, and February 1, 2022, the company identified 310 water events including water leaks, moisture, and condensation in the dry powdered infant formulas production areas.
In April, House Appropriations Committee Chair Rosa DeLauro (D-CT) released the 34-page document, compiled by a former Abbott employee outlining what DeLauro called a “damning list of allegations of wrongdoing at this factory.”
The whistleblower complaint included allegations that Abbott:
- Falsified records relating to testing of seals, signed verifications without adequate knowledge, failed to maintain accurate maintenance records, and shipped packages with fill weights lower than what was on the label
- Released untested infant formula
- Hid information during a 2019 FDA audit
- Employed lax practices associated with clean in place procedures
- Lacks adequate traceability capabilities
- Failed to take corrective measures once the company knew their testing procedures were deficient
And on May 16, the U.S. Justice Department filed a complaint and entered a consent decree that would allow the company to resume production. The complaint alleges that Abbott officials manufactured infant formula under conditions that didn’t comply with regulations and failed to safeguard against contamination with dangerous bacteria such as Cronobacter.
Under the proposed consent decree, Abbott will be required to retain an independent expert to review operations at the Sturgis plant and make sure they are in compliance with the law. “It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan, and employee training programs,” according to a Justice Department press release.
