A preliminary report of the US Food and Drug Administration (FDA) stated that the Abbott Nutrition at Sturgis, Michigan, did not take the necessary steps to prevent the product from becoming contaminated during its manufacturing process.
In its recent inspection, which FDA conducted between January 31 and March 18, the FDA also said that Abbott Nutrition failed to ensure that surfaces in contact with the formula were maintained to prevent contamination, CNN reports.
Findings in the preliminary report
The recent findings in the preliminary report called Form 483 do not represent the agency's final determinations of possible violations. The form is usually followed by formal reports and a warning letter to the company.
The two most notable observations in the 2022 Form 283 include:
- Abbott Nutrition failed to establish a process control system to ensure that infant formula does not become contaminated due to the presence of microorganisms in the formula or the processing environment.
- The company did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.
The recent report also found Cronobacter sakazakii on a "scoop hopper", which holds the plastic scoop placed inside the baby formula cans. The bacteria were also found on the floor around the product dryers.
The sampling conducted by Abbott in February detected Cronobacter bacteria 20 times within two weeks in low, medium, and high care areas where the company produced powdered formula.
An internal investigation by Abbott to determine the February contamination reported that the bacteria likely entered the building with contractors who walked on the roof and failed to clean their shoes before entering production areas property.
The FDA will also conduct a programmatic review to ensure the maximum effectiveness of agency programs and policies related to infant formula and special medical food complaints.
FDA assured that the review is a top priority for the agency and will be done as efficiently as possible, making sure not to interfere with immediate recall response activities.
Statement of Abbott Nutrition
According to the Abbott Nutrition statement, in response to the recent report, the company reviews the US FDA's observations provided in Form 483. The company said it takes the matter very seriously and is working with the FDA to "implement corrective actions."
The company also maintains that no Cronobacter sakazakii or Salmonella was found in any testing products distributed to consumers. Abbott nutrition also noted that the Cronobacter sakazii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii from the reported cases. The company also highlighted the removal of the Salmonella case from its investigations.
Last month, Sen. Patty Murray and Sen. Bob Casey wrote to Abbott CEA Robert Ford for answers about its response to dangerous bacterial contamination of several powder infant formula products. In a statement released on Tuesday, Casey said that other reports establish a pattern of Abbott Nutrition's inadequate efforts to keep its product safe.
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