WASHINGTON– U.S. regulators have historically inspected infant formula factories at least once a year, but they did not inspect any of the top three manufacturers in 2020, according to federal records reviewed by The Associated Press.
When they finally entered an Abbott Nutrition formula factory in Michigan after a two-year gap, they found standing water and lax sanitation procedures. But the inspectors only offered voluntary suggestions for resolving the issues and issued no formal warnings.
Inspectors returned five months later after four infants who had consumed formula from the factory suffered from bacterial infections. They found bacterial contamination inside the factory, leading to a four-month shutdown and turning a supply shortage into a full-blown crisis that left parents scrambling to find formula and forced the United States to airlift products from overseas.
The gap in inspections of infant formula factories, caused by the COVID-19 pandemic, is under new scrutiny from Congress and government watchdogs investigating the series of missteps that led to the crisis. A recent bill would require the Food and Drug Administration to inspect infant formula facilities every six months. And the government’s health inspector general has launched an investigation into the FDA’s handling of Abbott’s facility, the largest in the United States.
Abbott resumed production at the plant earlier this month under a legally binding agreement with the FDA, but the nationwide shutdown and shortage revealed how concentrated the industry has become in the states. United States, with a handful of companies accounting for around 90% of the market.
As COVID-19 swept across the United States in early 2020, the FDA pulled most of its field safety inspectors, skipping thousands of routine factory inspections.
The FDA conducted more than 800 “mission-critical” inspections in the first year of the pandemic, the agency said in a statement. Regulators selected facilities for inspection based on whether they posed a specific safety risk or were necessary to produce an important medical therapy.
Only three of the 23 establishments in the country that manufacture, package or distribute infant formula were selected. The FDA resumed routine inspections in July 2021.
Inspection records reviewed by the AP show gaps as large as 2.5 years between FDA inspections in 2019 and the return of regulators to factories belonging to the three major formula makers: Abbott, Reckitt and Gerber.
In fact, the FDA has yet to revisit a key plant owned by Reckitt and two owned by Gerber, according to agency records. All of these facilities operate around the clock to boost formula production in the United States.
“The FDA would have had a better chance of detecting these issues if it had been inspecting during the pandemic,” said Sarah Sorscher, food safety specialist at the Center for Science in the Public Interest. She acknowledged the difficult trade-off the FDA faced in urging its inspectors to reduce their exposure to COVID-19. “There was certainly a price to pay for protecting their workers during this time.”
Infant formula makers have been “consistently identified as a high priority during the pandemic,” and there is currently no backlog of inspections, the agency told the AP in response to inquiries about the shortcomings. The agency said it had skipped about 15,000 U.S. inspections due to COVID, but had already dialed in about 5,000, exceeding its own goals.
Under current law, the FDA is only required to inspect milk-preparation facilities every three to five years, but the agency routinely inspected facilities every year — until the pandemic.
“Our top priority now is to meet the urgent need for infant formula in the U.S. market, and our teams are working day and night to make that happen,” the FDA said.
But outside experts say the gap in inspections signals a blind spot in the government’s response effort, which has been successful in preventing shortages of drugs and other medical supplies.
FDA Commissioner Robert Califf said regulators knew closing the Abbott plant would create supply problems, but there was little evidence of urgency between when inspectors closed. the factory in February and the recent emergency measures to allow more imports from overseas.
Longtime food safety experts see a deeper problem at the highest levels of the FDA, where doctors and medical scientists have for decades prioritized oversight of drugs and medical products over food.
“It’s very difficult for them to get into this area because they don’t have the knowledge, knowledge and experience,” said Steven Mandernach, executive director of the Association of Food and Drug Officials, who represents the state. higher level inspectors.
The FDA shares oversight of food production and safety with the United States Department of Agriculture. FDA inspections of food facilities peaked in 2011 and have declined for most years since, despite increased funds and congressional powers. The FDA said that while US inspections have decreased, inspections of foreign facilities have increased.
There is no certainty that additional inspections during COVID-19 would have prevented contamination issues at the closed Sturgis, Michigan plant. And Abbott says its products have not been directly linked to the infections, two of which have been fatal.
But the factory has had previous problems, including a formula recall in 2010 due to possible contamination from insect parts.
“I think facilities that had known issues that could pose a food safety risk should have been part of FDA’s critical mission work,” Mandernach said. “And this facility would have been among those.”
The lack of regular inspections — or even the threat of inspections — can lead to culture shifts at factories like Abbott’s, Mandernach noted.
“If you’re driving down the highway and you know the state troopers were furloughed, could you go a little faster than if you knew there was a trooper on duty?” asked Mandernach.
Follow Matthew Perrone on Twitter: @AP—FDAwriter.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.