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https://www.propublica.org/article/baby-formula-abbot-sturgis-michigan- shortages-unsanitary-conditions-workers-say

Workers at one of the nation’s largest baby formula plants say the Abbott Laboratories facility is engaging in unsanitary practices similar to those
that led it to temporarily shut down just three years ago, sparking a nationwide formula shortage.

Current and former employees told ProPublica that they have seen the plant
in Sturgis, Michigan, take shortcuts when cleaning manufacturing equipment
and testing for microbes. The employees said leaks in the factory are
sometimes not fixed, a dangerous problem that can promote bacterial
growth. They also said workers at the facility do not always take required swabs to check for pathogens while performing maintenance during
production. Supervisors have urged workers to increase production and have retaliated against workers who complained about problems, the employees
said.

One worker complained to the Food and Drug Administration in February,
saying the plant has experienced “persistent leaks” and “unaddressed contamination issues,” according to correspondence between the worker and
the agency viewed by ProPublica. Water and chemicals have pooled on the
floor, the worker said. In one spot, white sweetener oozed from a pipe and formed a pile like a stalagmite on top of a tank used for blending, the employee said.

The complaints come as the Trump administration is dismantling wide swaths
of the federal government — including conducting mass layoffs at the FDA —
and filling some key regulatory positions with industry-friendly voices.
The new head of the FDA division that oversees baby formula is a corporate lawyer who previously defended Abbott against a lawsuit.

The workers ProPublica spoke to said they did not want to be named because
they feared repercussions from Abbott management, but they felt compelled
to speak up out of concern that a baby who drank formula made at the plant would fall ill.

“I can’t have this on my conscience,” one of the workers said.

Abbott called workers’ assertions “untrue or misleading,” denied their
claims about retaliation and said the company “stands behind the quality
and safety of all our products including those made at Sturgis.” In a statement, a spokesperson said that since 2022, the company had increased
plant staff by 300 people, spent $60 million on upgrades and stationed
multiple food-safety consultants there on weekdays. The company said the
plant often takes more than 10,000 environmental swabs across the facility
in a month to check for microbes.

“We believe Sturgis is the most inspected, tested, and swabbed infant
formula manufacturing facility in the U.S., and likely in the world,” the statement said.

That said, Abbott conceded that the plant acted “outside of our quality process” in one incident from last May.

Workers told ProPublica that, instead of retrieving a portable pump, an employee used a piece of cardboard from a trash bin to funnel coconut oil,
a formula ingredient, into a tank during production of the company’s Pure
Bliss by Similac Organic brand. Abbott said the cardboard “was reactively
used to prevent spilling onto the floor.” The company denied that there
was a trash receptacle in the area and said plant practice was for
cardboard to be stacked on a pallet before being recycled.

Food-safety laws require companies to use clean tools to transfer
ingredients, not a makeshift implement like cardboard, said Patrick Stone,
a former FDA inspector who works as a consultant.

“No one would think that’s a proper use,” he said. “It’s not something
that’s been cleaned and verified it’s clear of contamination.”

Abbott, however, downplayed the significance of the incident, saying it occurred early in the manufacturing process, before pasteurization, and
the product underwent “enhanced testing” that came back negative for
microbes.

“We acknowledge that this is outside of our quality process, and this has
been addressed,” Abbott’s statement said. The company said the plant had a discussion with the employee reiterating the proper procedure.

Employees complained about the incident at the time and some hoped the
plant had destroyed the formula. But a few weeks later, they received an
email, which ProPublica viewed, that said the plant had released all
batches “not just on time, but early.” It congratulated workers for an
“amazing milestone and achievement for Sturgis.”

Abbott said there have been no medical complaints related to the lot. The
brand is advertised as suitable for newborns.

In another incident in February, an employee said that the company had
signed off on the use of an amino acid that was 10 months past its manufacturer’s “best by” date. A photo of the label viewed by ProPublica
showed a best by date of April 2024. The law requires that ingredients in formula not expire before the formula as a whole, Stone said.

Abbott said that the powder’s expiration date had been “extended,” which
it said regulations permit in some cases, after the company used third-
party testing to confirm its nutrient levels.

But the worker said the amino acid powder was “chunky” and employees
refused to add it to a formula mixture. It had been manufactured in
October 2023.

Abbott told ProPublica that two containers of amino acid mix were, in
fact, placed on hold due to “crustiness” and later destroyed. “When we
find products that don’t meet all specifications, we dispose of them,” the company said.

Some of the workers said they’ve felt pressure not to disrupt the
manufacturing process. At one meeting in February, a worker said a senior manager told employees the plant needed to improve its profit margins by
either increasing production or reducing the amount of formula it was discarding as unusable.

Abbott disputed the idea that it is cutting corners to make more formula.

“Any assertion that quality is being sacrificed at the expense of volume
and profit is patently untrue,” it said. The company said that in 2024,
Abbott made 41% less formula at Sturgis than it had in 2021, the year
before the shutdown.

For its part, the FDA did not respond to questions about whether an
inspection or investigation is taking place at the Sturgis plant in
response to the complaint it received. The agency said it generally does
not comment on “potential or ongoing inspections or investigations.”

In a statement, the FDA said that it “takes reports related to infant
formula seriously and follows up as appropriate.”

The case could prove to be a major test for President Donald Trump’s
second administration, which just last month announced an effort to
“ensure the ongoing quality, safety, nutritional adequacy, and resilience
of the domestic infant formula supply.” Dubbed Operation Stork Speed, it promised to increase ingredient testing and communicate regularly with consumers and the industry “as significant developments occur to ensure transparency, including information regarding nutrients and health
outcomes.”

“Egregiously Unsanitary” Conditions
The Abbott employees’ concerns come three years after the company
voluntarily recalled several formula brands, including Similac, Alimentum
and EleCare, and temporarily halted production at Sturgis amid reports of unsanitary conditions and infant deaths.

A former plant employee in 2021 had told the FDA that the plant was using
lax cleaning practices, falsifying records and releasing untested infant formula to the public. FDA inspectors found leaking equipment valves,
standing water and a type of bacteria at the plant called Cronobacter sakazakii, which is common but can be deadly for young babies. Company documents showed the manufacturer had even discovered the bacteria in its finished formula in 2019 and 2020, the report said. Food-safety laws
require companies to test samples of their formula to check the nutrient content and look for harmful microorganisms.

Those inspection findings were “shocking,” a former FDA chief said later.
He called the plant “egregiously unsanitary.”

Initial reports said several infants were hospitalized and two died from
an illness caused by the Cronobacter bacteria after drinking formula made
at the Sturgis plant, according to an inspector general’s report. Between December 2021 and June 2022, it said the FDA received a total of 16
consumer complaints involving infant deaths and Sturgis facility products.

The report said the FDA did not directly link drinking formula from the
plant to any of the infants’ illnesses or deaths. Abbott said no unopened Abbott formula has ever tested positive for Cronobacter.

Still, in May of 2022, Abbott signed a consent decree with the Department
of Justice and the FDA and committed to following improved procedures at
the facility. The decree is still in effect. It says the company can be
fined up to $30,000 a day for violations, with a maximum of $5 million in
a year.

The plant’s nearly four-month-long shutdown in 2022 sparked a nationwide formula shortage, which was worsened by COVID-19-related supply-chain
issues. Store shelves emptied of formula, leaving parents desperate. Some babies developed symptoms such as spitting up and diarrhea after being
forced to switch brands, researchers found. Nearly half of parents in one survey of primarily low-income families said they’d resorted to at least
one unsafe feeding practice, such as watering down formula.

Abbott said it disagreed “vehemently” with the FDA chief’s comments on the Sturgis plant being unsanitary, and it said the former employee who filed
the 2021 complaint with the agency was dismissed for “serious violations”
of its food-safety policies. Abbott said the employee’s specific claims
were not supported by the FDA. “It’s time to stop giving credence and fame
to individuals with questionable agendas” that have led to “unnecessary” formula shortages, Abbott said.

New Complaints Arise as FDA Is Cut
It’s unclear how the Trump administration, with its reduced federal
workforce, will respond to the newest complaints. The administration
recently eliminated 3,500 FDA jobs as part of extensive cuts in federal
health workers’ ranks. While officials said the reductions will not impact inspectors, the agency did not answer a question about whether any of the employees being let go are involved in inspection or enforcement for the Sturgis facility.

The White House also recently installed a corporate lawyer in a top FDA
post, putting him in charge of the agency’s regulation of formula. Kyle Diamantas, acting deputy commissioner for human foods, previously defended Abbott against a lawsuit in which families alleged the company failed to
warn them about a deadly bowel condition that premature babies who are fed formula have a greater risk of developing. Abbott has appealed a verdict
in which it was ordered to pay $495 million.

Meanwhile, at the Department of Agriculture, officials disbanded an
advisory committee that had been studying the threat of Cronobacter contamination in powdered formula. The USDA said at the time that it did
so to comply with an executive order seeking to reduce bureaucracy but it remained committed to food safety. The Heritage Foundation’s Project 2025 blueprint for a Trump presidency had listed as one of its goals
reevaluating “excessive regulation” of infant formula.

Families using formula aren’t being protected if the FDA is acting like a partner to companies like Abbott instead of overseeing them, said Jennifer Pomeranz, a professor and expert in public health and food policy at New
York University who has served as a witness for plaintiffs suing Abbott
over the bowel condition. She called Diamantas’ appointment the “perfect example of regulatory capture.”

In its statement to ProPublica, the FDA said it is “committed to enhancing regulatory oversight of all infant formula manufacturers to help ensure
that the industry is producing infant formula under the safest conditions possible.”

The Sturgis plant is a major supplier of formula in the United States and
had been producing about 20% of the nation’s formula when it shut down in
2022. Abbott provides formula to more than half of babies in the government-backed nutrition-assistance program, called WIC, that
subsidizes families’ formula purchases. The company has contracts to be
the sole source of formula for WIC recipients in 36 states and Washington, D.C., as of August of last year.

“If You Have Leaks, Forget About It”
Since the 2022 consent decree, FDA records show it has completed 10 inspections, including a multiweek review that was underway when employees
said the cardboard incident took place. (The company says that according
to its records, it has been inspected by FDA 12 times in that period.) No action was required in response to most of those visits, according to a database that tracks FDA inspections.

But for one inspection that ended in December 2022, the FDA issued a
citation that noted concerns related to contamination prevention, worker hygiene and the handling of consumer complaints, documents say.

A report from that inspection — completed just seven months after Abbott
signed the consent decree — said the agency found problems similar to
those that had shut down the plant.

The report noted, among other things, six instances of employees failing
to collect required swabs to test for bacterial contamination after
cleaning up a leak. It also said inspectors found “apparent insects and
dust like debris” near formula-making equipment. “You did not establish a system of process controls covering all stages of processing that was
designed to ensure that infant formula does not become adulterated due to
the presence of microorganisms in the formula or in the processing environment,” the report said.

Stone, the former FDA inspector who is now a consultant, said the citation
is significant. “FDA should have really hammered on them harder,” he said,
“but they’re weak and they’re scared.”

Without taking those swabs and testing them, the company cannot know if
the formula is contaminated, Stone said.

“Unless you’re monitoring your environment, you don’t know what’s in your environment,” he said. “If you have leaks, forget about it. You don’t know what’s in there.”

Abbott said it “has addressed all FDA observations” from 2022. FDA
inspectors have raised no major issues since then, the company said.

In 2023, Abbott confirmed the Department of Justice had opened a criminal investigation into conduct at the plant. A spokesperson for the
department’s Western District of Michigan did not respond to a request for information about the investigation’s status. Abbott did not respond to a question about the probe but said at the time that it was “cooperating
fully.” The Securities and Exchange Commission and Federal Trade
Commission were also scrutinizing the company after the problems surfaced
in Sturgis. Spokespeople for the SEC and FTC, which released a report on
the formula supply disruptions, declined to comment. Abbott did not
respond to questions about the investigations.

More recently, some employees who spoke to ProPublica said plant leaders
have urged them to speed up production — even though the consent decree
aimed to add more safety protocols. “Imagine a 10-page rule book you’re
told you have to operate by no matter what,” one said. “No deviations.
You’re doing that, and then your boss says, ‘You’re not doing your job
fast enough.’”

The workers said some employees have pushed supervisors to follow sanitary procedures more closely and at times refused to run equipment until their concerns about sanitation were met, even as they feared losing their jobs. Abbott is one of the largest and highest-paying employers in the largely
rural area near the Indiana border. The plant’s tall white tower,
emblazoned with a large green “a,” looms over nearby homes.

An employee said that since the consent decree, he had witnessed leaks of formula, oil, chemicals and water that were not cleaned up, fixed or
documented properly. Sometimes, the worker said, supervisors resisted
shutting down machinery — always a money-losing proposition — to address a leak. The worker reported seeing a leak that hadn’t been handled correctly
more than once a month. “It’s all over,” the employee said.

Photos taken in the plant show equipment whose outer surface was streaked
with drips from formula ingredients that had leaked. In one instance, an absorbent mat had been placed on the floor to catch drips. Procedures
require the plant to contain leaks, fix equipment and test the area for pathogens, workers say. Leaks can become breeding grounds for bacteria.

Abbott said “in a facility the size of Sturgis, with literally miles of
pipes, leaks, drips, and condensation are inevitable.” The plant has a
team it deploys quickly to contain leaks, then swab, test and sanitize the area, the company said. The plant aims to limit standing water and
sanitize regularly to prevent bacterial growth, Abbott said, and it runs
six times the number of Cronobacter tests on finished product samples as required by federal regulations.

“Abbott has a quality policy that we make our products as if they were for
our own families,” the company’s statement said. “If quality were not our
first priority Abbott would not still be here at 137 years.”

A contractor Abbott hired to improve its processes has raised concerns
about the facility not following protocols or procedures in past audits
but cited no such problems in the audit completed earlier this year, said Mansour Samadpour, co-founder of IEH Laboratories and Consulting Group.
IEH, which began its work after the consent decree, reports back to Abbott
and the FDA on what the plant needs to correct. Neither Abbott nor IEH
provided a copy of the most recent audit.

Samadpour declined to detail the earlier concerns. He said it was possible
an employee could miss a swab, but said there’s no systemic problem. He
said he does not have concerns about sanitary practices in the plant.

“If I have any concerns, they will hear from me and FDA will hear from
us,” said Samadpour, who spoke with ProPublica at Abbott’s request. “That
is our job.”


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November 5, 2024 - Congratulations President Donald Trump. We look
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The disease known as Kamala Harris has been effectively treated and
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We live in a time where intelligent people are being silenced so that
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Durham Report: The FBI has an integrity problem. It has none.

Thank you for cleaning up the disaster of the 2008-2017 Obama / Biden
fiasco, President Trump.

Under Barack Obama's leadership, the United States of America became the
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