Many infant formula factories were not inspected because of COVID – CBS Detroit

WASHINGTON (AP) – U.S. regulators have historically inspected infant formula factories at least once a year, but did not inspect any of the top three manufacturers in 2020, according to federal records reviewed by the Associated Press.

When they finally walked into an Abbott Nutrition formula factory in Michigan after a two-year gap, they found stagnant water and lax sanitation procedures. But inspectors only offered voluntary suggestions to correct the problems and issued no formal warning.

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Inspectors would return five months later after four babies who consumed powdered formula from the plant suffered bacterial infections. They found bacterial contamination inside the factory, leading to a four-month shutdown and turning a supply shortage into an all-out crisis that sent parents rushing to find formula and forced the US to ship products from abroad.

The gap in infant formula factory inspections, brought on by the COVID-19 pandemic, is receiving fresh scrutiny from Congress and government watchdogs investigating the series of mistakes 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 inspector general of health has launched an inquiry into the FDA’s handling of the Abbott facility, the largest in the U.S.

Abbott resumed production at the factory earlier this month under a legally binding agreement with the FDA, but the shutdown and nationwide shortages have exposed just how concentrated the industry has become in the US, with a handful of companies accounting for around 90% of the market.

When COVID-19 swept the US in early 2020, the FDA pulled most of its safety inspectors out of the field, skipping thousands of routine plant inspections.

The FDA performed more than 800 “mission critical” inspections during the first year of the pandemic, the agency said in a statement. Regulators have selected facilities for inspections based on whether they present a specific safety risk or are necessary to produce an important medical therapy.

Only three of the country’s 23 facilities that manufacture, package or distribute formula have been cut. The FDA resumed routine inspections in July 2021.

Inspection records reviewed by the AP show gaps of up to 2½ years between FDA inspections in 2019 and when regulators returned to plants owned by the three major formula manufacturers: Abbott, Reckitt and Gerber.

In fact, the FDA has yet to return a key plant owned by Reckitt and two owned by Gerber, according to agency filings. All of these facilities are operating 24 hours a day to drive US formula production.

“The FDA would be more likely to detect these issues if it were inspecting during the pandemic,” said Sarah Sorscher, a food safety expert at the Center for Science in the Public Interest. She acknowledged the difficult trade-off the FDA faced in pulling its inspectors to reduce its exposure to COVID-19. “There was certainly a price to pay for protecting your workers during this time.”

Baby formula manufacturers have been “consistently identified as a high priority during the pandemic” and there are currently no delays in inspections, the agency told the AP in response to questions about the gaps. The agency said it has skipped about 15,000 inspections in the US due to COVID, but has already done about 5,000 of them, surpassing its own targets.

Under current law, the FDA is only required to inspect formula facilities every three to five years, but the agency has consistently inspected facilities annually — until the pandemic.

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“Our top priority right now is meeting the urgent need for infant formula in the US market, and our teams are working around the clock to help make that happen,” the FDA said.

But outside experts say the gap in inspections shows 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 the plant closing in February and recent emergency measures to allow more imports from abroad. .

Longtime food safety experts see a deeper problem at the highest levels of the FDA, where doctors and medical scientists for decades have prioritized oversight of drugs and medical products over food.

“It’s very challenging for them to engage in this area because they don’t have the training, knowledge and experience in it,” said Steven Mandernach, executive director of the Association of Food and Drug Officials, which represents state-level 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 in most years since, despite increased funds and Congressional powers. The FDA said that while US inspections have declined, inspections of foreign facilities have increased.

It’s not certain that extra inspections during COVID-19 would have avoided contamination problems at the closed Sturgis, Michigan plant. And Abbott says its products have not been directly linked to the infections, two of which were fatal.

But the plant has had previous problems, including a 2010 formula recall due to possible contamination with insect parts.

“I think facilities that have known issues that could cause a food safety risk should be part of the FDA’s mission-critical work,” Mandernach said. “And this facility would be among those.”

The lack of regular inspections — or even the threat of them — can lead to changes in the culture of plants like Abbott’s, Mandernach noted.

“If you’re driving down the highway and you know the state troopers were laid off, could you go a little faster than if you knew there was a police officer on duty?” asked Mandernach.

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