FDA 483 - Abbott Laboratories - September 24, 2021

During an inspection conducted from September 20-24, 2021, at Abbott Nutrition's Sturgis, MI infant formula manufacturing facility, the FDA observed several objectionable conditions. Key findings included a failure to maintain the building in a clean and sanitary state, evidenced by standing water in critical processing areas and the inappropriate use of a forklift designated for liquid processing in a dry area. Personnel hygiene practices were also deficient, with an operator touching non-food contact surfaces before handling infant formula ingredients without proper glove sanitization, and exposed wrists entering ingredient bags. Furthermore, the inspection identified issues with equipment maintenance, specifically the lack of calibration for critical flow and pressure sensors used in processing. Abbott Nutrition also failed to ensure proper installation of certain processing equipment and did not adequately monitor the temperature of thermal processing equipment, a critical control point for infant formula production. These observations indicate practices that could lead to contamination or impact product quality, falling under the regulatory purview of the Federal Food, Drug, and Cosmetic Act. Abbott Nutrition is expected to respond to these observations with timely and effective corrective actions to ensure compliance.