- After FDA approval, Abbott could restart the site within two
weeks; from the time of restart it would take six to eight weeks
before product is available on shelves
- Abbott will continue to import formula from FDA-registered
facility in Ireland to help
alleviate near-term supply shortage
- CDC concluded its investigation with no findings of a link
between Abbott formulas and infant illnesses
PARK, Ill., May 16, 2022
/PRNewswire/ -- Abbott (NYSE: ABT) has agreed to enter into a
consent decree with the U.S. Food and Drug Administration (FDA)
related to its Sturgis, Mich.,
infant formula plant. The decree is an agreement between FDA and
Abbott on the steps necessary to resume production and maintain the
facility. This does not affect any other Abbott plant or operation.
The decree is subject to court approval.
"Our number one priority is getting infants and families the
high-quality formulas they need, and this is a major step toward
re-opening our Sturgis facility so
we can ease the nationwide formula shortage. We look forward to
working with the FDA to quickly and safely re-open the
facility," said Robert B. Ford,
chairman and chief executive officer, Abbott. "We know millions of
parents and caregivers depend on us and we're deeply sorry that our
voluntary recall worsened the nationwide formula shortage. We will
work hard to re-earn the trust that moms, dads and caregivers have
placed in our formulas for more than 50 years."
Once the FDA confirms the initial requirements for start-up have
been met, Abbott could restart the site within two weeks. The
company would begin production of EleCare®,
Alimentum® and metabolic formulas first and then begin
production of Similac® and other formulas. From the time
Abbott restarts the site, it will take six to eight weeks before
product is available on shelves.
Abbott has been working on corrective actions since the FDA
inspection and submitted a response and corrective action plan to
FDA on April 8. Even before its
formal response, Abbott had begun working to implement improvements
and take corrective action. Some of these actions included
reviewing and updating education, training and safety procedures
for both employees and visitors, as well as updating protocols
regarding water, cleaning and maintenance procedures at the
facility. Abbott immediately implemented corrections to address the
items that the FDA raised in its observations provided at the
conclusion of the inspection. The company has also been making
upgrades to the plant.
Detailed Findings of Investigation
After a thorough
investigation by FDA, Centers for Disease Control and Prevention
(CDC) and Abbott, and review of all available data, there is no
conclusive evidence to link Abbott's formulas to these infant
- CDC concluded its investigation with no findings of a link
between Abbott formulas and infant illnesses.
- Abbott conducts microbiological testing on products prior to
distribution and no Abbott formula distributed to consumers tested
positive for Cronobacter sakazakii or
- All retained product tested by Abbott and the FDA during the
inspection of the facility came back negative for
Cronobacter sakazakii and/or Salmonella. No
Salmonella was found at the Sturgis facility.
- The Cronobacter sakazakii that was found in
environmental testing during the investigation was in non-product
contact areas of the facility and has not been linked to any known
- Genetic sequencing on the two available samples from ill
infants did not match the strains of Cronobacter
sakazakii found in our plant. Samples from ill infants did
not match each other, which means there was no connection between
the two cases.
- In all four cases, the state, FDA and/or CDC tested samples of
the Abbott formula that was used by the child. In all four cases,
all unopened containers tested negative.
- Open containers from the homes of the infants were also tested
in three of the four cases; two of the three tested negative. The
one positive was from an open container from the home of the
infant, and it tested positive for two different strains of
Cronobacter sakazakii, one of which matched the strain that
caused the infant's infection, and the other matched a strain found
on a bottle of distilled water in the home used to mix the formula.
Again, neither strain matched strains found in our plant.
- The infants consumed four different types of our formula made
over the course of nearly a year and the illnesses took place over
several months in three different states.
Cronobacter sakazakii is naturally occurring
and found nearly everywhere in the environment. Powdered infant
formula manufacturers periodically detect it in their plants, and
FDA, in issuing its infant formula Current Good Manufacturing
Practices (cGMP) regulations, stated that, based on current
technologies, it is not possible to produce a sterile powdered
infant formula (79 Fed. Reg. 7987). However, Abbott has no
tolerance for Cronobacter sakazakii in its production
environment, and no Abbott product was distributed with
Cronobacter sakazakii contamination. The company is
further strengthening its processes and using advanced technologies
to enhance sanitization procedures, product tracking and
monitoring as well as training protocols for employees and
"Our safety and quality processes meet even the toughest
scrutiny and we're committed to continuously improving our
processes and protocols," said Mr. Ford. "Nutrition is fundamental
to Abbott and to our goal of improving the lives of more than 3
billion people by decade's end. We intend to set the standard for
the industry, raising the bar on both safety and quality."
Abbott's Efforts to Support Formula Supply Since the
Since the recall, the company has taken numerous
measures to mitigate the supply shortage. Specifically, it has
focused on production in its Cootehill, Ireland, facility to serve state Special
Supplemental Nutrition Program for Women, Infants and Children
Abbott has been working with the U.S. Department of Agriculture
(USDA) and WIC agencies and paying rebates on competitive
products in states where Abbott holds the WIC contract, when
Similac is not available. Abbott said Friday it
will continue to pay rebates for competitive products through
August 31. This means program
participants will continue to be able to obtain formula free of
charge, whether it is Similac or formula from another manufacturer.
Additionally, the company has:
- Air shipped millions of cans of infant formula powder into the
U.S. from our FDA-registered facility in Cootehill, Ireland.
- Prioritized infant formula production at our Columbus, Ohio, facility, converting other
liquid manufacturing lines into manufacturing Similac liquid
ready-to-feed and ramped production at our other U.S. manufacturing
site in Casa Grande, Arizona, for
powder infant formula.
- Offered an increased number and value of coupons available for
all infant formula products, including Similac
liquid ready-to-feed, to enable customers to purchase formula,
either free or deeply discounted.
- Been running other facilities at full capacity to help
replenish the supply in the market.
Abbott Guidance Unchanged
Abbott is confirming its
previously issued full-year 2022 guidance for adjusted diluted
earnings per share from continuing operations of at least
$4.70. Abbott will incur one-time
specified charges for expenses related to the consent decree which
have not yet been quantified. However, Abbott does not expect
that these expenses will have a material impact on Abbott's
consolidated financial statements.
Abbott is a global healthcare leader that
helps people live more fully at all stages of life. Our portfolio
of life-changing technologies spans the spectrum of healthcare,
with leading businesses and products in diagnostics, medical
devices, nutritionals and branded generic medicines. Our 113,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews.
— Private Securities Litigation
Reform Act of 1995 —
A Caution Concerning
Some statements in this news release may be
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. Abbott cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Economic, competitive,
governmental, technological and other factors that may affect
Abbott's operations are discussed in Item 1A, "Risk Factors" in our
Annual Report on Form 10-K for the year
ended Dec. 31,
2021, and are incorporated herein by reference.
Abbott undertakes no obligation to release publicly any revisions
to forward-looking statements as a result of subsequent events or
developments, except as required by law.