Abbott enters Consent Decree with FDA on Cronobacter infant formula outbreak and recall

Here are the highlights of the Consent Decree:

• Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility
• Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure 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. 

The U.S. Food and Drug Administration is announcing important updates on its ongoing work to increase the supply and availability of infant formula in the U.S. On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan infant formula production facility, and Abbott voluntarily ceased production at this facility as well as initiated a voluntary recall of certain products.

Today, a proposed consent decree of permanent injunction between the FDA and Abbott Nutrition, as well as three Abbott principals, was filed in the U.S. District Court for the Western District of Michigan. Under the proposed consent decree, which is subject to court approval and entry, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility. The proposed consent decree obliges Abbott to take actions that are expected to ultimately result in an increase of infant formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility. When the company decides to restart production at this facility, it must conform with the provisions of the proposed consent decree and meet FDA food safety standards. If contamination is identified, the company must notify the FDA, identify the source of the problem and conduct a root-cause investigation before resuming production.

In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements. On Jan. 31, the FDA commenced a for-cause inspection and identified Cronobacter sakazakii, a bacterium that can potentially cause severe foodborne illness primarily in infants, in the facility and observed significant operational deficiencies. While the agency’s inspection was ongoing, Abbott Nutrition voluntarily recalled certain powdered infant formula products and voluntarily shut down its facility to implement corrective actions that address issues raised by the FDA.

Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure 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.

Here is Abbott’s position:

After a thorough investigation by FDA, Centers for Disease Control and Prevention (CDC) and Abbott, and review of all available data, there is no conclusive evidence to link Abbott’s formulas to these infant illnesses. Specifically:

• CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.
• Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
• All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility.
• The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.
• Genetic sequencing on the two available samples from ill infants did not match the strains of Cronobactersakazakii found in our plant. Samples from ill infants did not match each other, which means there was no connection between the two cases.
• In all four cases, the state, FDA and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
• Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
• The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.