The Food Safety Modernization Act (FSMA) Human Food Audit Checklist was developed as a tool for assisting food processors with implementation of FSMA. This 70-page checklist incorporates Title 21 Code of Federal Regulations (CFR) Part 1 Subparts H (Registration of Food Facilities) and O (Sanitary Transportation of Human and Animal Food) and 21 CFR 117 (Preventive Controls for Human Food Hazard Analysis and Risk-Based Preventive Controls and Current Good Manufacturing Practices) with hints, comments, and definitions. The checklist was reviewed by Food and Drug Administration experts and food company personnel to validate its usefulness. It can be modified to fit any food processor or regulation.