What is the purpose of FDAs compliance program for medical foods?
The Compliance Program enables FDA inspectors to (1) obtain information regarding the manufacturing/control processes and quality assurance programs employed by domestic manufacturers of medical foods through establishment inspections, (2) collect domestic and import surveillance samples of medical foods for nutrient and microbiological analyses, and (3) take action when significant violations of the Federal Food, Drug and Cosmetic Act (or related regulations) are found.