WASHINGTON – U.S. regulators have historically inspected baby formula factories at least once a year, but they didn’t inspect any of the top three manufacturers in 2020, according to federal filings reviewed by The Associated Press.
Two years later, when they finally walked into an Abbott Nutrition formula plant in Michigan, they found stagnant water and lax sanitation. However, the inspectors only offered voluntary suggestions to fix the problems and did not issue a formal warning.
Inspectors returned five months later after four infants who consumed powder formulation made from the plant contracted bacterial infections. They found bacterial contamination at the factory, leading to a four-month shutdown and turning a simmering supply shortage into a full-blown crisis that left parents scrambling to find formula and forcing the US to air-freight produce from overseas.
The gap in baby food facility inspections caused by the COVID-19 pandemic is coming under renewed scrutiny from Congress and government watchdogs, who are investigating the series of missteps that led to the crisis. A new bill requires the Food and Drug Administration to inspect infant formula facilities every six months. And the government’s health inspector has opened an investigation into how the FDA was handling Abbott’s facility, the largest in the United States
Abbott resumed production at the plant earlier this month under a legally binding deal with the FDA, but the closure and nationwide shortage showed how concentrated the industry has become in the U.S., with a handful of companies accounting for about 90% of the market .
As COVID-19 swept across the US in early 2020, the FDA pulled most of its safety inspectors from the field, skipping thousands of routine facility inspections.
The FDA conducted more than 800 “mission-critical” inspections in the first year of the pandemic, the agency said in a statement. Regulatory agencies selected facilities for inspection based on whether they posed a specific safety risk or were needed to produce an important medical therapy.
Only three of the country’s 23 facilities that manufacture, package or distribute formula made it into the cut. The FDA resumed routine inspections in July 2021.
Inspection records reviewed by the AP show gaps of up to 2 1/2 years between FDA inspections in 2019 and regulators returning to the plants of the top three formula makers: Abbott, Reckitt and Gerber.
In fact, according to agency records, the FDA has yet to return to a key plant owned by Reckitt and two owned by Gerber. All of these facilities operate 24/7 to boost US formula production.
“The FDA would have had a better chance of spotting these issues if they had been conducting inspections during the pandemic,” said Sarah Sorscher, a food safety specialist at the Center for Science in the Public Interest. She acknowledged the difficult trade-off the FDA faced in getting its inspectors to reduce their exposure to COVID-19. “Certainly there was a price for protecting their workers during this time.”
Baby formula manufacturers have been “consistently prioritized throughout the pandemic,” and there is currently no inspection backlog, the agency told the AP in response to inquiries about the gaps. The agency said it skipped about 15,000 U.S. inspections due to COVID, but it has already made up about 5,000 of those, surpassing its own goals.
Under current law, the FDA is only required to inspect formula factories every three to five years, but the agency consistently inspected facilities annually — until the pandemic.
“Our top priority now is to meet the urgent infant formula needs of the US market, and our teams are working day and night to make that happen,” the FDA said.
But outside experts say the gap in inspections points to a blind spot in the government’s response efforts, which have been successful in preventing shortages of medicines and other medical supplies.
According to FDA Commissioner Robert Califf, regulators knew closing Abbott’s plant would cause supply problems, but there was little between when inspectors shut down the plant in February and the recent emergency response to allow more imports from abroad signs of urgency.
Veteran food safety specialists see a deeper problem at the highest levels of the FDA, where physicians and medical scientists have prioritized drug and medical device oversight over food for decades.
“It’s very difficult for them to even get involved in this area because they don’t have the background, knowledge and experience in it,” said Steven Mandernach, executive director of the Association of Food and Drug Officials, which represents the state – inspectors.
The FDA shares oversight of food production and safety with the US Department of Agriculture. FDA inspections of food facilities peaked in 2011 and have declined most years since, despite increased resources and powers from Congress. The FDA said U.S. inspections had declined, but inspections of foreign facilities had increased.
There is no certainty that additional inspections during COVID-19 would have prevented contamination issues at the closed Sturgis, Michigan facility. And Abbott says its products have not been directly linked to the infections, two of which were fatal.
But the facility has had previous problems, including a 2010 formula recall due to possible contamination with insect parts.
“I think facilities that had known issues that could cause a food safety hazard should have been part of FDA’s mission-critical work,” Mandernach said. “And this facility would have been among them.”
The lack of regular inspections — or even the threat of them — can lead to changes in culture at facilities like Abbott’s, Mandernach noted.
“If you’re driving down the freeway and you know the state troopers are on furlough, could you drive a little faster than if you knew there was a soldier on duty?” Mandernach asked.
Follow Matthew Perrone on Twitter: @AP_FDAwriter.
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