Abbott – FDA reach agreement to resume baby formula production at Michigan factory

FDA information is given in the context of the situation baby formula is in short supply taking place in the US. Abbott’s Michigan milk factory was previously closed after a contaminated milk powder incident that killed two children in February.

In its latest announcement, Abbott said the agreement, also known as the Consensus Judgment, outlines the steps needed to restart manufacturing at the Michigan plant.

Under the proposed settlement, Abbott would need to perform remedial actions at the plant. The company is also required to have an independent expert review and evaluate the operation of the Sturgis facility to ensure compliance with the law.

The agreement also requires Abbott to implement sanitation plans, environmental monitoring plans, employee training programs, and product testing. The FDA added that Abbott was also required to stop production and notify the agency immediately if any contamination problems were detected.

Once the FDA confirms the requirements are met, Abbott can restart the plant within two weeks. However, Abbott warns, it will still take six to eight weeks after resuming operations before the product hits shelves.

Shelves of infant formula at a store in San Antonio, Texas, USA are empty, May 10, 2022. (Photo: Reuters)

Along with that, the agreement between Abbott and the FDA still has to be reviewed by the court after the US Department of Justice filed a complaint on May 16. The complaint states that the establishment did not comply with regulations designed to ensure the quality and safety of baby powdered milkincluding protection against the risk of infection.

Mr. Robert Ford, Abbott’s President and CEO, said he regrets the situation. At the same time, he said, the company has already started taking action to fulfill the improvement requests and corrective actions.

Abbott, the company that makes the popular Similac brand of infant formula used by millions of American homes, announced a voluntary product recall on February 17 following an incident involving two children. That makes it even more difficult for American families to find powdered milk products amid the market context, supply chain problems and Abbott’s massive recall.

According to Datasembly, which collects information from more than 11,000 retailers, the average out-of-stock rate for baby formula in the US stood at 43 percent at the start of May. The US produces about 98% of the baby formula it consumes, and the government of President Joe Biden is planning to increase imports to address this.

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