i- FDA updated its infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The program comprehensively outlines the agency’s approach towards inspections, sample collection, sample analysis, and compliance activities to help ensure infant formula products in the US are safe and nutritious.
- As our readers know, in September 2022, FDA published its internal evaluation of the infant formula response which identified five major areas of need to ensure the safety of the food supply. Specifically, the evaluation found that FDA’s infant formula compliance program lacked specificity regarding Cranobacter and is limited by scientific gaps related to this pathogen. The evaluation recommended that FDA review and update its compliance program and associated Compliance Policy Guide for infant formula manufacturers to ensure it reflects current science, provides consistent industry oversight, and provides better tools for investigators and compliance officers.
- In line with these recommendations, the updated compliance program includes instructions for annual environmental sampling of Cranobacter and Salmonella at powdered infant formula facilities. It also provides instruction for FDA notification if a sample tests positive for Cranobacter or Salmonella, or if a sample is found to have nutrients that are above or below required levels per the FDA’s infant formula regulation. The program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated, and also provides additional background information on the risks associated with Cranobacter and Salmonella in infant formula products.
FDA Updates Compliance Program for Infant Formula
Wednesday, October 11, 2023
