Abbott Nutrition Form 483 has been released by the FDA in the investigation of four Cronobacter illnesses linked to recalled Similac powdered infant formula. The three forms were released after inspections were conducted by the FDA at Abbott’s facility in Sturgis, Michigan.
All of the sick infants, who lived in Minnesota, Texas, and Ohio, are reported to have consumed powdered infant formula that was produced at that facility. The inspections were conducted on September 16 – 24, 2019, Sepatember 20 – 24, 2021, and January 31 – March 18, 2022. The notice states, “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 20sting22 inspectional findings.”
The Form 483 Reports
During the 2019 inspection, the FDA inspector noted, “You did not test a representative sample of a production aggregate of a powdered infant formula at the final product stage and before distribution to ensure that the production aggregate meets the required microbiological quality standards.” The firm collected 30 samples of Similac Pro Sensitive, when the document stated they collected 60 samples for Salmonella testing.
In the 2021 inspection, the Abbott Nutrition Form 483 report states, “You did not maintain a building used in the manufacture, processing, packing, or holding of infant formula in a clean and sanitary condition.” Standing water was observed in locations in the facility; standing water can be a risk factor for pathogen growth in food production facilities.
Also in the 2021 inspection, personnel working directly with infant formula, its raw materials, packaging, or equipment did not wash their hands thoroughly in a hand washing facility at a suitable temperature after their hands may have become soiled or contaminated. And an instrument used to measure, regular, or control a processing parameter was not properly maintained.
The 2022 Inspection
Finally, in the 2022 report, the FDA states that the company 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. More specifically, environmental samples collected by the FDA confirmed the presence of Cronobacter sakazakii on zone two and zone three surfaces in medium and high care areas of powdered infant formula production.
In the packaging room for a filler line, the hinge attachment and bolt heads on the top, clear cover of the scoop hopper was swabbed and tested positive for Cronobacter. This hopper is utilized to feed scoops, which are replaced directly inside infant formula containers and contact product. At the time of swabbing, Similac Pro-Total Comfort with HMO infant formula powder was being packaged.
Standing water was observed in the powdered infant formula production areas: This is a repeat observation from the 2021 FDA inspection. From 1/1/20 – 2/1/22, the firm identified 310 water events including water leaks, moisture, and condensation in dry powdered infant formula production areas.
In addition, the firm did not ensure that all surfaces that contacted infant formula were maintained to protect contamination by any source. The facility’s dryers have a history of internal deterioration dating back to September 2018 according to the report.
The investigation file on a complaint did not include the determination as to whether a hazard to health exists and the basis for that determination. The four complaints were lodged with the FDA starting in September 2021. The company’s complaint investigations did not identify the root causes of the Cronobacter sakazakii and Salmonella Newport illnesses reported from those complaints. (The Salmonella illness was removed from the investigation by the CDC in March 2022.) The complaint investigations treated infant death and infant illnesses the same.
Retained samples are evaluated for microbial analysis when requested by Medical Safety and Surveillance for specific cases for Adverse Events, and when it is determined during the investigation of a complaint that there is a potential that the distributed product does not comply with specifications.
During the investigation of the complaint about the infant death associated with 7 ounce Similac Pro Total Comfort infant powdered formula, the team did not request that retained samples be tested for this lot in accordance with Complaint Management and Investigation standard operating procedures.
Finally, Abbott Nutrition Form 483 for the 2022 inspection found that personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wear nccssary protective apparel. Employees did not spray the soles of their shoes with sanitizer. Contractors walked on the facility roof with “captive footwear,” and did not sanitize or change their shoes when they went back into the building.
Cronobacter Illnesses and Deaths
All of the infants who were sickened after consuming Similac powdered infant formula were hospitalized. Two of the infants, who lived in Ohio, died.
Powdered infant formula cannot be made sterile, according to manufacturers. Liquid ready-to-use formulas are sterile. Preparing powdered formulas requires several distinct and important steps.
Cronobacter infections in infants, especially infants who were born prematurely, can lead to meningitis and sepsis, which can be life-threatening. Any infant exhibiting the symptoms of a Cronobacter infection, including excessive crying, poor feeding, and very low energy, should be taken to a doctor as soon as possible.
If your infant has been sickened with a Cronobacter or Salmonella infection after consuming recalled infant formula, please contact our experienced attorneys for help at 1-888-377-8900 or text us at 612-261-0856. Our firm represents clients in lawsuits against grocery stores and food processors, and families in wrongful death cases.
