The field inspector will submit the final 483 to his/her superiors; if the results are major enough, or Should the response into the 483 you submit is deemed insufficient, an FDA Warning Letter may very well be issued towards your agency. A Warning Letter may be the FDA's advisory observe https://nse-india74951.widblog.com/92931019/pharma-supplier-quality-audit-and-risk-management-for-dummies