Abbott Addresses Regulatory Inspections at Sturgis Facility Without Findings

Abbott Laboratories has stated that the U.S. Food and Drug Administration (FDA) concluded a 19-day inspection of its Sturgis, Michigan infant formula facility on April 4 without issuing any written Form 483 observations. The Michigan Department of Agriculture & Rural Development also concluded a two-day inspection of the plant on April 8, similarly without issuing any findings.

The company reiterated its stance that a recent ProPublica story about the facility was misleading and inflammatory, relying on anonymous sources with questionable motives rather than experts familiar with its operations. Abbott noted that independent third-party food safety consultants monitoring the plant weekly have not raised concerns about sanitary practices.

Abbott emphasized that the Sturgis facility is likely the most inspected and tested infant formula manufacturing plant in the U.S., and potentially globally. The company stated it tests six times the number of finished product samples required by federal regulation for Cronobacter and three times for Salmonella before releasing products. Thousands of environmental swabs are also taken monthly to check for microbes.

Products from the Sturgis plant undergo rigorous microbial testing for Cronobacter and Salmonella, with comprehensive reviews of sanitation records and batch audits. The company affirmed that its employees confidently feed their own family members formula produced at the facility. Abbott faced a significant recall and scrutiny in 2022 after four infants became ill and three died from Cronobacter or Salmonella infections, which were investigated for a potential link to the Sturgis plant's products.