The FDA (Food and Drug Administration), the health authority responsible for approving new drugs and new manufacturing sites, has a process for conducting pre-approval inspection (PAI) investigations like no other agency in its methodology. They have not delegated this responsibility to other agencies through mutual recognition programs.

They carry out numerous inspections in the workshop, observe the technicians performing their work, explore the quality systems to ensure that the quality systems are effective in guaranteeing product quality and look for any inconsistencies in the data and reports.

Their inspection is motivated by the examination of the quality systems, their processes, a perfect knowledge of the product, its process and the demonstration of its robustness.