FDA EIR - Abbott Laboratories - March 24, 2022

An FDA inspection of Abbott Nutrition, Division of Abbott Laboratories in Columbus, OH, was conducted from March 7 to March 24, 2022. This comprehensive, high-priority inspection focused on the manufacturing of infant formula and medical foods, initiated as a follow-up to consumer complaints regarding infant gastrointestinal distress and Salmonellosis. The inspection adhered to regulatory frameworks including Good Manufacturing Practices (GMPs), the Infant Formula Program, Medical Foods Program, and Preventive Controls for Human Food regulations. Investigators reviewed various operational areas, such as production, sanitation, environmental monitoring, allergen programs, and specific product lot records associated with the complaints. Crucially, the inspection concluded that the firm was in compliance with GMPs and infant formula regulations, finding no significant deviations in reviewed records or operations. Consequently, no FDA 483 Inspectional Observations were issued, indicating no required corrective actions from the agency during the closeout meeting. Four samples of infant formula and medical foods were collected as part of the inspection assignment.