As part of its ongoing efforts to strengthen the safety, resiliency, and oversight of the infant formula industry, the U.S. Food and Drug Administration (FDA) has updated its infant formula compliance program for agency investigators, laboratory analysts, and compliance officers. The compliance program is designed to comprehensively outline the agency’s approach to inspections, sample collection, sample analysis, and compliance activities.
In September 2022, FDA released an internal evaluation of the agency’s response to the infant formula safety and supply crisis, which was precipitated by a large-scale recall of products contaminated with Cronobacter sakazakii and the subsequent temporary shutdown of one of the largest infant formula producers in the U.S. The evaluation recommended that FDA review and update its infant formula compliance program to ensure that it reflected the latest science on Cronobacter and offered consistency and clarity on the agency’s inspection and compliance activities. In November 2022, as part of its prevention strategy for preventing Cronobacter contamination of infant formula, the agency committed to completing this review and update.