...Biden is done, stick a fork in him.
Some of the operational deficiencies that helped trigger the
massive shutdown of Abbott Nutrition's infant formula plant
earlier this year have also been found at some other companies'
factories, according to an ABC News investigation of some of the
other formula makers that have stepped in to help fill empty
American grocery shelves in the midst of the critical nationwide
shortage.
The pathogen that prompted those concerns, Cronobacter
sakazakii, can be widely found in the environment -- but in
infants, it can be deadly.
Its discovery inside Abbott's Sturgis, Michigan, plant prompted
a massive voluntary formula recall in February, after four
babies who had consumed Abbott's formula contracted a
Cronobacter infection. Two of the infants subsequently died,
although Abbott maintains there has not been conclusive evidence
that its formula caused the infant illnesses, since none of the
Cronobacter strains found at their plant matched the two samples
genetically sequenced from the sickened infants.
Ultimately, it was the combined findings of Cronobacter inside
Abbott's plant -- along with a pattern of serious operational
deficiencies and consumer complaints -- which led to its closure.
Abbott's shutdown ricocheted across the country, exacerbating
the supply shortage and forcing families to scramble for
alternatives in the hyper-concentrated formula market. In the
wake of Abbott's recall, other companies jumped in to ramp up
manufacturing to help mitigate the strain.
Yet within the last five years, those companies -- Reckitt's
Mead Johnson, Gerber, and Perrigo's PBM -- have also not been
immune to operational and even contamination-related concerns.
Nearly a decade's worth of FDA inspections obtained through the
regulatory intelligence company Redica Systems and reviewed by
ABC News have found the presence of Cronobacter in environmental
sampling, in critical and high-hygiene areas, and even in
finished product from some of these formula manufacturers'
American plants.
In some cases, investigators found crucial equipment in a state
that could nurture the spread of potentially dangerous
pathogens, according to inspection reports.
'Rigorously managing the environment'
Cronobacter is exceptionally hardy, experts say. It is also
"fairly common" in places like soil -- but that's exactly why
"rigorously managing the environment" in formula factories and
"taking proactive steps to prevent pathogens from creeping into
our foods" are particularly important, food safety expert Scott
Faber told ABC News.
Akin to a restaurant health inspector, the FDA performs no-
notice inspections of U.S. manufacturing facilities to ensure
companies are complying with manufacturing and cleanliness
standards; they also perform inspections when alerted by a
company that product contamination has been found -- or when
consumer complaints prompt a for-cause probe into whether the
company is upholding an acceptable standard.
ABC News has reviewed FDA inspection documents for the three
other domestic companies which, along with Abbott, have been
responsible for roughly 90% of the country's formula market.
The right set of circumstances can compound a perfect storm of
risk factors for potentially dangerous pathogens to survive,
experts say -- and that's especially worrisome when a
contaminant like Cronobacter lurks where food is made for
babies, who are among those most vulnerable to that germ.
"Especially for sensitive populations, that quality control is
so important. You don't want contamination to rise to a level
where it becomes a problem," Dr. Amy Edwards, a pediatrician and
associate medical director for infection control at UH Rainbow
Babies & Children's Hospital in Ohio, told ABC News. "That's why
inspections are meant to be incredibly invasive -- we have to
get close enough to zero contamination levels to be safe."
Mead Johnson
In August 2021, FDA investigators made a routine visit to Mead
Johnson's plant in Evansville, Indiana, where it has operated
for more than a century. An inspection report notifying the
company's management of objectionable conditions, called a Form
483, was issued, after investigators found the plant's data
wasn't recorded frequently enough to ensure proper sterility of
their product.
FDA investigators said that company records indicated
Cronobacter was found in one of the plant's rooms, and that the
area was subsequently sanitized. A plant operator was observed
not washing his hands between glove changes, and not changing
his gloves between touching non-food and food contact surfaces.
The employee was subsequently retrained, Mead Johnson told the
FDA, according to inspection documents. But it was not the first
time investigators had flagged concerns at one of Mead Johnson's
plants.
In late 2017, seven investigators visited Mead Johnson's plant
in Zeeland, Michigan, after the company had alerted the FDA that
two finished batches of Enfamil formula -- batches that had
already been exported from the country -- tested positive for
Cronobacter. An FDA inspection revealed that Cronobacter had
been found "in critical and high hygiene areas of the processing
environment on 26 occasions" between mid-January and late August
of 2017, documents obtained by ABC News show.
FDA investigators also said they found Cronobacter specifically
in areas that risked leading to "potential contamination" of
"food contact surfaces."
The potential problems the FDA discovered at the plant were
addressed in time for later inspections -- but food safety
experts told ABC News these issues can become a serious problem
if not immediately dealt with.
"Cronobacter is an environmental pathogen -- it's everywhere,"
food safety attorney Bill Marler said. "But it's really, really
bad to have it in infant formula."
Mead Johnson's plant had "multiple wall leaks," nonconformity
reports reviewed by the FDA said, as well as "equipment
condensation" in areas where positive Cronobacter samples were
later found.
"Leaks are the bane of infection control," Edwards said. "Water
is life; if you're not controlling your water, then you are not
controlling your bacteria."
The Zeeland facility submitted a corrective action plan,
promising "increased frequency of cleaning the areas where
positive results were identified, evaluation and inspection of
equipment" and "repairs to equipment and the facility as needed."
FDA investigators followed up with the Zeeland plant in spring
2018. The facility had retooled its sanitization procedures,
implemented dryer inspections, and made repairs to flooring,
water infiltration, and caulking.
Returning in March 2019, investigators noted the plant's
environmental monitoring program had identified and mitigated
several instances of Cronobacter in various areas of the plant.
In a statement to ABC News, Reckitt, of which Mead Johnson is a
division, maintained that the company manufactures their formula
"using the highest standards for quality and safety," adding
that whenever the FDA finds an issue they "immediately develop
and implement an action plan to address the issue."
Reckitt said they "regularly review and enhance" their
facilities' manufacturing processes "and invest in new
technologies and equipment," adding that their "robust operating
protocols meet or exceed the highest regulatory standards,"
which they employed while "safely" increasing infant formula
amid the shortage.
An FDA spokesperson, when asked for comment regarding their
investigators' findings of Cronobacter at multiple formula
companies' facilities, said the agency "takes its responsibility
seriously" to ensure the rigorous safety of American foods, and
that the agency is reexamining whether more can be done.
Based on a "close look at recent and historical findings" from
inspections, the FDA spokesperson said, "We will be looking at
what additional strategies could be employed to better prevent
microbial contamination during the production of powdered infant
formula," adding the agency is "conducting an evaluation" of
their response to the formula crisis "to determine what
additional steps should be taken to ensure the maximum
effectiveness of agency programs and policies related to infant
formula and medical food."
Nevertheless, said the spokesperson, "It is important to note
that it's a firm's responsibility to ensure the consistent
quality and safety of the products they produce."
"We are most interested in how aggressively a firm addresses and
responds to potential contamination," the FDA spokesperson said.
Steven Lynn, the former director of the FDA's pharmaceutical
Office of Manufacturing and Product Quality, told ABC News that
manufacturers' oversight "must be robust to assure no
adulterated product reaches the vulnerable infant population
they serve."
"It sounds easy, but it's not," said Lynn, an expert on good
manufacturing practices. "Problems can and do occur. That's a
fact of life."
Lynn, who reviewed the inspection documents obtained by ABC
News, noted that there appear to be "problematic similarities"
among some of the formula manufacturers' lapses in quality
control, including "issues with inadequate process controls,
including cleaning, sampling and ultimately controlling the
production environment to assure there is no microbial
contamination," he said.
Lynn said that FDA investigators did what they were supposed to
do: identify deficiencies for the companies to fix.
"The key is making sure the issues are thoroughly investigated,
and then implementing robust solutions to correct and prevent
them from reoccurring in the future," in order to ensure that
"safe formula is on the market," Lynn said.
Gerber
In August 2021, FDA investigators made a routine visit to Nestlé
Nutrition's Gateway facility in Eau Claire, Wisconsin, which
makes Gerber products. They found "dirty scoops used during the
previous production day" lying on a stainless steel table in one
of the raw material rooms, and "debris" on the floor.
It was determined that some cleaning activities were resulting
in water getting "trapped in cracks in the floor" and "onto
equipment located on lower decks."
In addition, Cronobacter was detected in an in-process powder
sample of infant formula.
The finished lot of that product was immediately destroyed.
FDA investigators discussed their findings and suggested
remedies with management, but did not issue a Form 483 at that
time, according to inspection documents reviewed by ABC News.
A Gerber spokesperson told ABC News that their infant formulas
go through up to 500 quality and safety checks, "many of which
are above and beyond regulatory requirements."
"If we find Cronobactor or any other contaminant in the product,
that is when we take the most extreme reaction," Scott Fitz,
Vice President of Technical & Production for Gerber told ABC
News.
"All the product in that batch is blocked, and all the batches
around that product are blocked," he said, adding that the
company thoroughly investigates the contaminant's origins and
destroys any impacted product.
"Given the sensitive consumer we're dealing with, we can't take
the chance of it getting to shelf," Fitz said. "This isn't about
regulation, it's about doing what's right."
PBM Nutritionals
After a routine visit in August 2019, the FDA issued a Form 483
identifying a cold storage temperature regulation deficiency at
the Milton, Vermont, plant of PBM Nutritionals, a subsidiary of
Perrigo, which makes store-brand formulas for retailers like
Walmart and Amazon.
Investigators found that some of the facility's data was not
specific enough "to ensure there is no significant growth of
microorganisms of public health significance" in their storage
tanks. Documents provided by the company to the FDA noted a
recent roof leak had overwhelmed the drainage system, and that,
upon inspection, environmental sample swabs tested positive for
Cronobacter before additional cleaning.
In a statement to ABC News, Perrigo said they are "proud" of
their compliance track record, adding that the Cronobacter
within the plant had been found by their own self-monitoring,
rather than by FDA investigators.
"Our facilities in Vermont and Ohio are in good regulatory
standing and remain compliant with all FDA processes and
procedures," they said.
Perrigo said they had hired independent experts "a few years
ago" to "enhance" their manufacturing processes and protective
measures. The company said the experts found their "aging
equipment could lead to concerns in the future," so they
invested approximately $110 million in improving formula plant
quality, and hired an additional 100 quality and sanitation
personnel.
Perrigo said that they had addressed the FDA's observation
regarding cold storage.
"Our quality control process is a continuous improvement
process, and any concerns found are promptly addressed," the
company said.
"Everybody knows what the persistent problems are that cause
bacterial contamination in product," said Marler, the food
safety attorney. "It's cracks, water, old equipment. It's when
companies stop realizing they're producing food that is going
into the bodies of babies and they start thinking about it as a
widget, as a commodity."
Patrick Stone, a former FDA investigator, says factories that
make infant formula should be held to a higher quality-control
standard than other mass market food products. But too often, he
said, "it actually takes an outbreak or something to happen
before people wake up and say .... 'Why is this happening?'"
Abbott Nutrition
After inspecting Abbott's Sturgis facility earlier this year,
FDA chief Dr. Robert Califf described the "shocking" and
"egregiously unsanitary conditions" investigators had found.
"Standing water; cracks in the key equipment that present the
potential for bacterial contamination to persist, particularly
in the presence of moisture; leaks on the roof; a previous
citation for inadequate hand washing," Califf testified before
Congress in May. "Many signs of a disappointing lack of
attention to the culture of safety, in this product that is so
essential to the lives of our most precious people."
Investigators discovered five strains of Cronobacter from
environmental sampling of Abbott's plant, and Abbott ultimately
agreed to shutter the facility and recall the formula.
Food safety experts ABC spoke with emphasized the importance of
establishing -- and adhering to -- a proactive protocol for
rooting out risk factors, before they snowball.
"You don't wait for the accident to happen before you build a
stoplight," said Faber, the food safety expert. "You probe your
factory for where pathogens could be lurking, and then adopt
critical controls to eradicate them.
"If we're seeing any of the conditions found at Sturgis in other
plants, we need to ask whether that philosophy has been
sufficiently embraced," he said.
"Abbott has a zero-tolerance policy for Cronobacter in our
plants, which is why we took the steps we did at Sturgis," an
Abbott spokesperson said. "Our highest priority is getting
babies safe, quality formula they need."
Further complicating the matter is that Cronobacter infection is
listed as a reportable illness by only one U.S. state:
Minnesota, where the first of the four infants was reported
infected after consuming Abbott's formula last September.
Because there are no national requirements that Cronobacter be
reported, doctors and labs are not required to report cases to
their local health department -- which leaves the FDA to rely on
consumer complaints and health care providers for on-the-ground
data regarding infections.
"Until you increase that oversight, you're going to limp from
mini-outbreak to mini-outbreak," Marler said.
A 'stringent enough' system?
In August 2017, a few months before the FDA found Cronobacter
inside Mead Johnson's Zeeland plant, a two-week old infant from
Illinois was declared brain dead after being diagnosed with a
Cronobacter infection. The infant had consumed "multiple lots of
Enfamil Newborn Premium ready-to-feed liquid milk product at the
hospital, and some product was sent home with the parents," FDA
inspection reports say.
But FDA sampling of the available formula was negative for
Cronobacter.
Reckitt told ABC News they "cooperate fully with the FDA to
investigate consumer complaints," underscoring that their
formula had never conclusively been proven as the cause of an
illness.
In the case of Abbott, too, no conclusive causation has been
proven between the Cronobacter found at the Sturgis plant and
infants' illness or death. Nevertheless, FDA chief Califf noted
in congressional testimony that "we cannot rule it out either,
as the confluence of events is highly unusual. There is no
dispute that the facility was unacceptably unsanitary."
"There is some room for human error, but not for persistent
human error," said Edwards. the pediatrician. "You have to have
your process in place. And you have to have a process for
monitoring your process to make sure it's always being followed."
When several controls fail at once, it risks prompting an
unfortunate domino effect and "raises important questions about
whether our current regulatory system is stringent enough,"
Faber said.
The FDA spokesperson told ABC News that the agency is assessing
whether their annual surveillance inspections of formula
facilities should include more environmental sampling going
forward, albeit in a way that "minimizes any disruptions to the
supply chain."
In June, ABC News was first to report that the Health and Human
Services' Office of Inspector General had launched an audit into
how the FDA responded leading up to the recall and closure of
Abbott's Sturgis plant.
The CDC says Cronobacter infections are rare, but serious in
infants -- noting that powdered formula can be contaminated at a
processing facility, or at home. Because Cronobacter can survive
so well -- on kitchen counters, on sinks, or in a manufacturing
plant -- the CDC recommends that families using formula wash
hands frequently around infants, thoroughly clean bottles, and
safely store any powdered formula, or, if possible, use liquid
formula.
"There are babies out there whose lives depend on formula. So
what happens when the thing that you're giving your baby is
actually the thing that makes them sick?" Edwards said. "That is
incredibly scary. For parents, for all of us."
ABC News' Eric M. Strauss contributed to this report.
https://abcnews.go.com/US/infant-formula-makers-abbott-faced-
cronobacter-contamination-operational/story?id=87268233