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The FDA Two-Track GMP Inspection Strategy Compliance Program Template includes information regarding mandatory points to be evaluated, Track I and Track II inspections, and instructions for reviewing records. During the inspection, the investigator will record observations of areas inspected on form FDA 483. The areas to be inspected will depend on the circumstances of the investigation. For Class I devices, complaint files and MDR will usually be all that is investigated unless major problems are discovered.
The Two Track strategy requires a comprehensive GMP inspection (i.e., a complete systems audit of the quality assurance program) every four years and a limited GMP inspection at the intervening two year mark if, and only if, the firm at the two year mark meets the conditions specified in this Compliance Program.