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A12 HEALTH
Tuesday 14 June 2022

Many baby formula plants weren't

inspected because of COVID

portant medical therapy.
Only three of the nation's 23
facilities that make, pack-
age or distribute formula
made the cut. The FDA re-
sumed routine inspections
in July 2021.
The inspection records re-
viewed by the AP show
gaps as large as 2 1/2 years
between FDA's 2019 in-
spections and when regu-
lators returned to plants
owned by the three lead-
ing formula manufacturers:
Baby formula is displayed on the shelves of a grocery store in Abbott, Reckitt and Ger-
Carmel, Ind. on May 10, 2022. ber.
Associated Press In fact, the FDA still has yet
to return to one key plant
WASHINGTON (AP) — U.S. government watchdogs in- owned by Reckitt and two
regulators have historically vestigating the series of mis- owned by Gerber, accord-
inspected baby formula steps that led to the crisis. ing to agency records. All
plants at least once a year, A recent bill would require those facilities are operat-
but they did not inspect the Food and Drug Admin- ing around the clock to
any of the three biggest istration to inspect infant boost U.S. formula produc-
manufacturers in 2020, ac- formula facilities every six tion.
cording to federal records months. And the govern- "The FDA would have had
reviewed by The Associ- ment's inspector general more chances to catch
ated Press. for health has launched an these issues if they'd been
When they finally did get inquiry into the FDA's han- inspecting during the
inside an Abbott Nutrition dling of Abbott's facility, pandemic," said Sarah
formula plant in Michigan the largest in the U.S. Sorscher, a food safety spe-
after a two-year gap, they Abbott resumed produc- cialist with the Center for
found standing water and tion at the plant early this Science in the Public Inter-
lax sanitation procedures. month under a legally bind- est. She acknowledged the
But inspectors offered only ing agreement with the difficult trade-off the FDA
voluntary suggestions for FDA, but the shutdown and faced in pulling its inspec-
fixing the problems, and is- nationwide shortage ex- tors to reduce their expo-
sued no formal warning. posed how concentrated sure to COVID-19. "Certain-
Inspectors would return the industry has become in ly there was a price to pay
five months later after four the U.S., with a handful of for protecting their workers
infants who consumed companies accounting for during that time."
powdered formula from roughly 90% of the market. Baby formula manufac-
the plant suffered bacterial As COVID-19 swept across turers were "consistently
infections. They found bac- the U.S. in early 2020, the identified as a high prior-
terial contamination inside FDA pulled most of its safe- ity during the pandemic,"
the factory, leading to a ty inspectors from the field, and there is currently no
four-month shutdown and skipping thousands of rou- backlog of inspections,
turning a festering supply tine plant inspections. the agency told the AP in
shortage into a full-blown The FDA did conduct more response to inquiries about
crisis that sent parents than 800 "mission critical" the gaps. The agency said
scrambling to find formula inspections during the first it skipped about 15,000 U.S.
and forced the U.S. to airlift year of the pandemic, the inspections due to COVID,
products from overseas. agency said in a statement. but it has already made up
The gap in baby formula Regulators selected facili- about 5,000 of those, ex-
plant inspections, brought ties for inspections based ceeding its own goals.
on by the COVID-19 pan- on whether they carried a Under current law, the FDA
demic, is getting new scru- specific safety risk or were is only required to inspect
tiny from Congress and needed to produce an im- formula facilities every
three to five years, but the
agency has consistently in-
spected facilities annually
— until the pandemic.
"Our top priority now is ad-
dressing the urgent need
for infant formula in the U.S.
market, and our teams are
working night and day to
help make that happen,"
FDA stated.q