Baby Formula Plants Went Without Inspections Due to COVID

In midst of the national baby formula shortage, the government is reevaluating its approach to baby formula plant inspections.

A bill introduced early June would require the Food and Drug Administration to inspect infant formula facilities every six months.
Facility Executive Staff

The three biggest manufacturers of baby formula were not inspected by U.S. regulators in 2020, according to federal records reviewed by The Associated Press. While traditionally, inspectors have visited baby formula plants at least twice a year, around 15,000 inspections were put on hold due to the pandemic.

When inspectors saw the Abbott Nutrition’s Sturgis, MI baby formula plant after two years, they saw lax procedures and standing water. Four months later, they returned after reports of four bacterial infections among infants who consumed powdered formula from the plant.

During the second inspection, regulators uncovered a series of violations, which included bacterial contamination, a leaky roof, and lax safety protocols. The Food and Drug Administration (FDA) closed down Abbott’s Michigan factory as a result, which led to the national baby formula shortage crisis in the U.S. in 2022.

Inspections may not have prevented the bacterial infections, as Abbott maintains that its products were linked to infections, but the Michigan plant has had issues in the past. In 2010, the company issued a formula recall due to possible contamination with insect parts.

“I think facilities that had known problems that could cause a food safety risk should have been part of FDA’s mission critical work [during the pandemic],” Steven Mandernach, executive director of the Association of Food and Drug Officials, which represents state-level inspectors, told the Associated Press. “And this facility would have been among those.”

To prevent this situation from happening again, a recent bill was proposed that would require the FDA to inspect infant formula facilities every six months.

Latest In Baby Formula Shortage

Shortly after resuming production earlier this month, Abbott Nutrition’s Sturgis, MI baby formula plant stopped production again after severe weather caused flooding in the facility on Monday, June 13.

The company is reviewing the damage and re-sanitizing the facility after several areas were impacted, and says that it expects to resume formula production and distribution within a few weeks. Abbott will stop producing its EleCare specialty formula, the Associated Press reports, but the company is confident that there’s currently enough supply to meet demand. When the plant does reopen, it will take six to eight weeks before product is available on the shelves.

Food and Drug Administration (FDA) Commissioner Dr. Robert Califf called the flood at the plant “an unfortunate setback and a reminder that natural weather events can cause unforeseen disruptions in supply chains.”

As the Abbott facility is out of commission, the U.S. government is importing thousands of pounds of formula from oversees, including London and Ireland.

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