The FDA has released documents showing a pattern of problems with food safety practices at the infant formula production plant implicated in an outbreak of illnesses that includes two deaths.

Form 483 documents from inspections in 2019, 2021 and 2022 of Abbott Nutrition’s Sturgis, MI, facility, show problems at the plant, according to the Food and Drug Administration.

Findings in the FDA Form 483 documents from the inspections include:

  • Abbott Nutrition 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.
  • Abbott Nutrition did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.

A representative of Abbott Nutrition provided the following statement:

“We are currently reviewing the U.S. FDA’s 483 observations from the inspection of our powder formula manufacturing in our Sturgis, Mich., facility. We’re taking this very seriously and are working closely with the FDA to implement corrective actions. While there are actions we need to take to address the FDA observations, it is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers. Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases. This follows the FDA’s removal of the Salmonella case from its investigation earlier this month.”

The FDA has reported in recent weeks that an inspection running from January through early March this year yielded positive test results from environmental samples for Cronobacter, the bacteria behind the outbreak that has sickened at least five infants. Two of the babies have died, but their deaths remain under investigation. The first sick child was reported in September 2021.

“The FDA is releasing the FDA Form 483s from three inspections conducted at Abbott Nutrition’s facility on Sept. 16-24, 2019Sept. 20-24, 2021, and Jan. 31-March 18, 2022. The inspectional observations in these Form 483s do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. FDA will take appropriate action in the future — if warranted — as we continue to evaluate the 2022 inspectional findings,” according to a statement issued with the documents.

During the 2022 investigation representatives from Abbott Nutrition have said that the company had previously found Cronobacter in the production plant, but not in samples of finished infant formula.

The FDA inspection of the plant this year showed numerous problems with equipment and the environment in the production facility, according to federal documents. 

Some problems included duct tape on the floor, water found pooling on the floors, shoe sanitizers were not being used correctly, some dryers had a history of being in deteriorating condition dating back to at least 2018, Cronobacter on numerous pieces of equipment including a scoop hopper.

In the 2019 report, the FDA noted that Abbott did not test a representative sample of a production aggregate of a powdered infant formula at the final product state and before distribution to ensure that the production aggregate met the required microbiological quality standards.

In the 2021 report, the FDA findings included Abbott’s failure to maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition. There was standing water, a forklift being used improperly, pallets stored in the wrong areas, and a fan with “extensive debris and dust-like buildup” “blowing the direction of the (redacted) cabinet.”

In 2021 the FDA inspectors also observed employees not washing their hands thoroughly. They also did not properly use and change gloves as necessary to maintain clean food contact surfaces.

Parts of the FDA reports have been redacted. 

Ongoing recall and consumer advice
The FDA is continuing to advise consumers not to use Abbott’s recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package. Products are included in the recall if they have all three of the following items on their packaging:

  • the first two digits of the code are 22 through 37 and
  • the code on the container contains K8, SH, or Z2, and
  • the expiration date is 4-1-2022 (APR 2022) or later.

In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code 27032K80 (can) / 27032K800 (case). Additional recall information for the initial recall is available on the FDA website. 

The recalled products have the potential to be contaminated with Cronobacter, a bacterium that can cause severe foodborne illness primarily in infants. Cronobacter infections are rare but are especially high risk for newborn infants.

Cronobacter bacteria can cause severe, life-threatening infections called sepsis or meningitis, which is an inflammation of the membranes that protect the brain and spine. Symptoms of Cronobacter infections may include poor feeding, irritability, temperature changes, yellow skin and whites of the eyes, grunting breaths, and abnormal body movements. Cronobacter infection can also cause bowel damage and may spread through the blood to other parts of the body.

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