Judge approves consent decree for struggling infant formula maker, clearing way for production to restart
The 33-page agreement outlines the steps the manufacturer must take to restart production at its Sturgis, MI manufacturing facility. Once Abbott completes the to-do list to the FDA’s satisfaction, the company says it would take 2 weeks to resume formula production at the facility.
“There are a number of steps to take once the plant can restart, including restarting equipment, testing and multiple ingredient testing and verification,” the Abbott spokesperson said. , Jonathon Hamilton, in an email to CNN.
The agreement requires Abbott to clean and disinfect its facilities and all equipment therein. The manufacturer should also engage an independent expert third party to review their processes. The company is also encouraged to review and modify its environmental monitoring program, its product sampling and analysis plans and its employee training programs.
After production lines restarted, Abbott said it would take at least six to eight weeks for new cans of formula to be delivered to stores, the company said in a press release.
Abbott said it submitted a corrective action plan to the FDA on April 8. But even before that official response, he had been working on improvements, including reviewing and updating education, training and safety procedures for employees and visitors and updating water protocols. , cleaning and maintenance procedures of the installation.
Additionally, Abbott said it immediately took steps to address the issues raised by the FDA at the end of its inspection.
“Our number one priority is to provide infants and families with the high-quality formulas they need, and this is a major step towards reopening our Sturgis facility so that we can alleviate the shortage of formulas at the nationwide. We look forward to working with the FDA to quickly and safely reopen the facility,” Abbott Chairman and Chief Executive Officer Robert B. Ford said in a press release. Millions of parents and caregivers depend on us, and we are deeply sorry that our voluntary recall has exacerbated the nationwide formula shortage. We will work hard to regain the trust that moms, dads and caregivers have placed in our formulas for over 50 years.”
Additionally, the FDA’s review of company records found that Abbott detected Cronobacter bacteria in batches of finished formulas produced in 2019 and 2020.
In preliminary findings, the FDA reported that Abbott had not established a process control system covering all processing steps to prevent contamination of preparations by microorganisms and that all surfaces that touched preparations for infants were not cared for to prevent contamination.
Ultimately, however, tests by the FDA and the US Centers for Disease Control and Prevention revealed that the genetic sequences of Cronobacter samples from inside the plant did not match any of the bacteria isolated from the plants. sick children or formula inside their homes. , so no link was found with the Sturgis installation.
Genetic samples from sick babies also did not match, suggesting there was no link between their cases, Abbott said in his press release. Cronobacter bacteria are commonly found in the environment.
Additionally, Abbott said, no infant formula distributed to consumers has tested positive for Cronobacter or Salmonella.
“Our safety and quality processes meet the most rigorous reviews and we are committed to continually improving our processes and protocols,” Ford said. “Nutrition is fundamental to Abbott and to our goal of improving the lives of more than 3 billion people by the end of the decade. We intend to set the standard for the industry, elevating the bar in terms of safety and quality.”
CNN’s Laura Smitherman contributed to this report.