U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020, according to federal records reviewed by The Associated Press.
When they finally did get inside an Abbott Nutrition formula plant in Michigan after a two-year gap, they found standing water and lax sanitation procedures. But inspectors offered only voluntary suggestions for fixing the problems, and issued no formal warning.
Inspectors would return five months later after four infants 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 festering supply shortage into a full-blown crisis that sent parents scrambling to find formula and forced the U.S. to airlift products from overseas.
The gap in baby formula plant inspections, brought on by the COVID-19 pandemic, is getting 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 inspector general for health has launched an inquiry into the FDA’s handling of Abbott’s facility, the largest in the U.S.
Abbott resumed production at the plant early this month under a legally binding agreement with the FDA, but the shutdown and nationwide shortage exposed how concentrated the industry has become in the U.S., with a handful of companies accounting for roughly 90% of the market.
As COVID-19 swept across the U.S. in early 2020, the FDA pulled most of its safety inspectors from the field, skipping thousands of routine plant inspections.
The FDA did conduct more than 800 “mission critical” inspections during the first year of the pandemic, the agency said in a statement. Regulators selected facilities for inspections based on whether they carried a specific safety risk or were needed to produce an important medical therapy.
Only three of the nation’s 23 facilities that make, package or distribute formula made the cut. The FDA resumed routine inspections in July 2021.
The inspection records reviewed by the AP show gaps as large as 2 1/2 years between FDA’s 2019 inspections and when regulators returned to plants owned by the three leading formula manufacturers: Abbott, Reckitt and Gerber.
In fact, the FDA still has yet to return to one key plant owned by Reckitt and two owned by Gerber, according to agency records. All those facilities are operating around the clock to boost U.S. formula production.
Baby formula manufacturers were “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 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, exceeding its own goals.
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.
There’s no certainty that extra inspections during COVID-19 would have prevented the contamination problems at the Sturgis, Michigan, plant that was shut down. And Abbott says that its products have not been directly linked to the infections, two of which were fatal.
Additional reporting by The Associated Press.