FDA 483 - Abbott Laboratories Inc. - May 02, 2023

This FDA Form 483 was issued to Abbott Laboratories Inc. in Casa Grande, AZ, following an inspection of their infant formula manufacturing facility. Observations included failures to establish adequate process controls to prevent microbial adulteration, specifically regarding water event management and environmental pathogen response. Additionally, the firm failed to ensure proper cleaning and sanitization of surfaces that contact infant formula, with inadequate documentation of drying times.