“The purpose of an FDA inspection is to determine a facility’s compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations of Title 21 of the U.S. Code of Federal Regulations (CFR), including, when applicable, Part 110 (Current Good Manufacturing Practices (GMP) in Manufacturing, Packing, or Holding Human Food) and any other U.S. regulations applicable to the specific type of food produced. For instance, canned foods will be inspected for compliance with the low-acid canned or acidified food regulations. Dietary supplements will be inspected for compliance with good manufacturing practices for dietary supplements. A single inspection may focus on multiple requirements, such as a canned tuna product that may be inspected for compliance with seafood hazard analysis and critical control point (HACCP) systems, canning regulations, labeling requirements and current GMPs.
Please note that these are routine inspections of individual facilities designed to evaluate a facility’s adherence with applicable U.S. laws and are NOT system audit visits designed to evaluate a country’s Competent Authority food safety system.”
