FDA 483 - Abbott Laboratories - March 18, 2022

The FDA inspected Abbott Laboratories dba Abbott Nutrition's infant formula manufacturing facility in Sturgis, MI, from January 31 to March 18, 2022, issuing a Form FDA 483. The inspection highlighted significant concerns regarding the prevention of microbial contamination, indicating violations of the Federal Food, Drug, and Cosmetic Act related to insanitary conditions and product adulteration.

Primary violations included a failure to implement adequate process controls to ensure infant formula safety. FDA environmental samples and the firm's own testing confirmed the presence of *Cronobacter sakazakii* and *Cronobacter spp.* in both the manufacturing environment (including product-contact surfaces) and finished infant formula products. The facility also experienced recurring issues with water leaks and moisture in production areas.

Further observations noted inadequate maintenance of product-contact surfaces, including unvalidated equipment drying processes and internal deterioration in dryers. Complaint investigations were deficient; the company failed to determine health hazards, identify root causes for severe illnesses and infant deaths linked to *Cronobacter sakazakii* and *Salmonella newport*, and did not consistently test retained product samples for serious adverse events. Additionally, personnel did not consistently adhere to sanitation protocols for footwear when entering production areas, posing a contamination risk. Abbott Nutrition is expected to undertake comprehensive corrective actions to resolve these critical issues and ensure regulatory compliance.