The U.S. Department of Justice filed court papers on Tuesday to allow Abbott Laboratories to resume manufacturing baby formula at a facility both the company and the government said tested positive for a bacteria that can cause sepsis. The precise documents — a complaint and a consent decree — “require the company to take specific measures designed to increase safety and ensure compliance” with federal statutes and administrative regulations, the DOJ said on Monday.
The White House has pointed to the closure of Abbott’s Sturgis, Mich. facility as the primary cause of a nationwide baby formula shortage. Abbott issued a voluntary recall after one baby died. The White House said a second infant also died after consuming what outgoing press secretary Jen Psaki called “tainted” formula, but Abbott has repeatedly asserted that testing has ruled out a causal connection between the presence of contaminants at the facility itself and any subsequent infant illnesses.
Abbott issued the voluntary recall “after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured” in Sturgis, according to a Feb. 17 statement from the company. The company later said on Feb. 28 that the cause of the infections had “not been determined” that its products were routinely checked for contaminants.
Testing found “evidence of Cronobacter sakazakii in the plant in non-product contact areas” at the Sturgis plant, according to Abbott. The company said it “found no evidence of Salmonella Newport.” It asserted several times that “no distributed product has tested positive for the presence of either of these bacteria.”
The DOJ countered on Monday that the overfall facility needed attention regardless of whether the products were cleared after testing:
In a complaint filed May 16, the United States alleged that Abbott, Division Vice-President of Quality Assurance Lori J. Randall, Sturgis Director of Quality Keenan S. Gale, and Sturgis Site Director TJ Hathaway manufactured powdered infant formula under conditions and using practices that failed to 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 Cronobacter sakazakii bacteria can live in dry foods, such as powdered infant formulas, and can cause deadly sepsis or meningitis in infants. The complaint further alleged that FDA testing of environmental samples taken in February detected Cronobacter sakazakii in the defendants’ manufacturing facility.
“The actions we are announcing today will help to safely increase the supply of baby formula for families,” said Attorney General Merrick B. Garland. “The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those 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 consent decree of permanent injunction. Under the proposed consent decree, which must still be reviewed and entered by a federal court, Abbott must retain outside expert assistance to bring its facility into compliance with the FDCA and good manufacturing practice regulations. Among other things, the expert will assist Abbott, under FDA supervision, in the development of plans designed to reduce and control the risk of bacterial contamination, and will periodically evaluate Abbott’s compliance with the FDCA, regulations, and the consent decree. The proposed consent decree 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 decree sets out what Abbott must do to resume safely manufacturing infant formula at the Sturgis facility, which will help to mitigate the shortage of infant formula while also protecting public health.
In a concomitant press release, Abbott said it would restart the manufacturing process for EleCare, Alimentum, and its “metabolic formulas first” and then resume 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,” the company said.
It continued by describing what corrective actions have been taken:
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.
“CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses,” the company said on Monday.
Abbott also on Monday revealed further results from tests on the formulas consumed by the ill infants.
- 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.
Abbott also said that federal regulations acknowledge that it is “not possible to produce a sterile powdered infant formula.”
“However, Abbott has no tolerance for Cronobacter sakazakii in its production environment, and no Abbott product was distributed with Cronobacter sakazakii contamination,” the company said.
“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 at 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.”
“Federal laws regarding the safe manufacture of food, particularly food for infants, must be rigorously enforced,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The proposed consent decree underscores the Department’s commitment to protecting our most vulnerable citizens while also ensuring access to an essential product.”
“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan,” said FDA Commissioner Robert M. Califf, M.D. “The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve. We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation. We are also taking a look at the supply of infant formulas developed by manufacturers across the country and around the world to determine if a reallocation of their distribution can be made to help get the right product to the right place, at the right time.”
“Parents who feed their babies formula must have confidence these products are safe,” said U.S. Attorney Mark Totten for the Western District of Michigan.
The DOJ also asked state attorneys general to use their offices “to ensure that vulnerable families are not taken advantage of during” the shortage and to report “any evidence of collusive price fixing, bid rigging, or market allocation” to the federal government.
Read the federal court paperwork below:
[Photo by Jeff Kowalsky/AFP via Getty Images]
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