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Re: Unsanitary Practices Persist at Baby Formula Factory Whose Shutdown Led to Mass Shortages, Workers Say

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Leroy N. Soetoro wrote:
> 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.”
> 
> 

Another blue milk story.  They are doing data compression now.

-- 
What can I say to have you at es?

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Unsanitary Practices Persist at Baby Formula Factory Whose Shutdown Led to Mass Shortages, Workers Say "Leroy N. Soetoro" <democrat-insurrection@mail.house.gov> - 2025-04-11 02:45 +0000
  Re: Unsanitary Practices Persist at Baby Formula Factory Whose Shutdown Led to Mass Shortages, Workers Say Mandrake the Perihelion <jfwaldby@gmail.com> - 2025-04-10 23:44 -0500

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