Baby formula maker signs court documents to resume production

Abbott’s manufacturing facility in Sturgis, Michigan is seen in a May 13, 2022 photo. The company initiated a voluntary recall after two infants became ill and two died with traces of it Cronobacter sakazakiia common environmental bacterium found in their systems after consuming formula made in the plant.

The US Department of Justice filed court papers on Tuesday to allow Abbott Laboratories to resume manufacturing baby formula at a facility that both the company and the government have tested positive for a bacterium that can cause sepsis. The detailed documents — a complaint and a consent decree — “oblige the company to take specific actions to enhance security and ensure compliance with federal laws and regulations,” according to the DOJ called On Monday.

The White House has notified of the closure from Abbott’s facility in Sturgis, Michigan as the primary Cause of a nationwide shortage of infant formula. dept issued a voluntary recall according to a baby died. The White House called A second child also died after consuming what the outgoing press secretary Jens Psaki called the “contaminated” formula, but Abbott has repeatedly claimed that testing has ruled out a causal link between the presence of contaminants in the facility itself and subsequent illnesses in the infant.

Abbott issued the voluntary recall “following four consumer complaints related toCronobacter sakazakiiorsalmonellaNewport in infants who had consumed Sturgis-made powdered infant formula, according to a Feb. 17 report Explanation by the company. The company later called on February 28 that the cause of the infections “has not been established” what its products are routinely checked for pollutants.

Testing found “Proof for Cronobacter sakazakii at the plant in non-product contact areas” at the Sturgis plant, Abbott said. The Company called it “found no evidence of this salmonella Newport.” It has been repeatedly claimed that “no product sold has tested positive for the presence of any of these bacteria.”

The DOJ countered Monday that the raid facility needed attention regardless of whether the products were released after testing:

In a complaint filed May 16, the United States alleged that Abbott, Division Vice-President of Quality Assurance Lori J RandallSturgis Director of Quality Keenan S Stormand Site Manager Sturgis TJ Hathaway Powdered infant formula manufactured under conditions and processes that do not comply with regulations designed to ensure the quality and safety of infant formula, including protection against the risk of contamination from bacteria such as Cronobacter sakazakii. The bacterium Cronobacter sakazakii can live in dry foods such as powdered infant formula and cause fatal sepsis or meningitis in infants. The complaint also alleged that FDA testing of environmental samples taken in February detected Cronobacter sakazakii at the defendant’s manufacturing facility.

“The measures we are announcing today will help increase the supply of baby food to families safely,” the attorney general said Merrick B Garland. “The Justice Department will vigorously enforce laws to ensure the safety of our food and other essential consumer products, and we will work with our partners across government to ensure these products are available to the American people.”

Here’s how the DOJ said the process will work:

Abbott has agreed to resolve the complaint in a proposed perpetual injunction consent decree. Under the proposed consent order, which is subject to review and registration by a federal court, Abbott will be required to use external expert assistance to bring its facility into compliance with the FDCA and good manufacturing practices. Among other things, the expert will assist Abbott in developing plans to reduce and control the risk of bacterial contamination, under the supervision of the FDA, and regularly assess Abbott’s compliance with the FDCA, regulations and the Consent Order. The proposed permit order also follows a thorough FDA inspection of the Sturgis facility and ongoing efforts by Abbott to address observations made during that inspection. The proposed consent order sets out what Abbott must do to resume safe infant formula manufacturing at its Sturgis facility, which will help alleviate infant formula shortages while protecting public health.

In an accompanying press release, Abbott said it would resume the manufacturing process for EleCare, Alimentum and its “metabolic formulas first” and then resume production of “Similac and other formulas.”

“From the time Abbott relaunches the website, it will take six to eight weeks for the product to hit shelves,” the company said called.

The corrective actions taken were then described:

Abbott has been working on corrective action since the FDA inspection and has submitted a response and corrective action plan to the FDA April 8th. Prior to his formal response, Abbott had begun implementing improvements and taking corrective actions. Some of these actions included reviewing and updating training, education and safety procedures for staff and visitors, and updating logs related to water, cleaning and maintenance procedures at the facility. Abbott immediately made corrections to address the issues that the FDA raised in its observations at the conclusion of the inspection. The company has also made upgrades to the facility.

“The CDC completed its investigation with no finding of an association between Abbott formulas and infant disease,” the company said called On Monday.

Abbott also on Monday further results revealed from tests of the formulas consumed by the sick infants.

  • The genetic sequencing of the two available samples from sick infants did not match the strains of Cronobacter Sakazakii found in our factory. Samples from sick infants did not match, meaning there was no link between the two cases.
  • In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula used by the child. In all four cases, all unopened containers tested negative.
  • In three of the four cases, open containers from the infants’ homes were also tested; Two of the three tested negative. One positive came from an open container at the infant’s home and tested positive for two different strains Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection and the other to a strain found on a bottle of distilled water in the house used to mix the formula. Again, none of the strains matched the strains found in our plant.

Abbott too called that recognize federal laws that “it is not possible to produce a sterile powdered infant formula”.

“Abbott has no tolerance for, however Cronobacter Sakazakii in its production environment and no Abbott product was distributed Cronobacter Sakazakii contamination,” the company said.

“Our top priority is giving infants and families the quality formula they need and this is an important step towards reopening ours.” sturgis facility so that we can alleviate the nationwide food shortage. We look forward to working with the FDA to quickly and safely reopen the facility.” called Robert B Ford, Chairman and Chief Executive Officer of Abbott. “We know millions of parents and caregivers depend on us, and we deeply regret that our voluntary recall has worsened the nationwide infant formula shortage. We will work hard to regain the trust that mums, dads and carers have placed in our formulas for more than 50 years.”

“Federal laws related to the safe manufacture of food, particularly infant formula, must be rigorously enforced,” the deputy assistant attorney general said Brian Boyton, Head of the Civil Division of the Ministry of Justice. “The proposed consent decree underscores the Department’s commitment to protecting our most vulnerable citizens while ensuring access to an important product.”

“Today’s action means that Abbott Nutrition has agreed to address certain issues the agency has identified at its Michigan infant formula manufacturing facility,” said the FDA commissioner Robert M. Califf, MD “The public should be assured that the agency will do everything it can to continue to ensure that the infant formula and other specialty foods it manufactures meet the FDA safety and quality standards that American consumers have come to expect and deserve. We recognize the difficulties parents and caregivers have faced in sourcing infant formula, and the FDA is focused on improving the availability of the country’s supply of these products, including taking new steps related to importation. We also take a look at the infant formula offerings that have been developed by manufacturers across the country and around the world to see if a reallocation of their distribution can be made to put the right product in the right place at the right time .”

“Parents who feed their babies infant formula need to be confident that those products are safe,” the US attorney said Markus Totten for the Western District of Michigan.

Also the DOJ asked the attorneys general to use its offices “to ensure vulnerable families are not exploited during” the shortage; and to report “any evidence of collusive price-fixing, bid-fixing or market-sharing” to the federal government.

Read the federal court filings below:

[Photo by Jeff Kowalsky/AFP via Getty Images]

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James Brien

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