If significant problems are identified during the inspection, FDA issues an FDA-483 (Inspectional Observations form) to the company’s management at the inspection close-out meeting. Facilities may use this meeting to request clarification, to demonstrate to the FDA inspection team any corrections that were implemented during the inspection, and to explain any corrections the facility intends to make at a later time. After completing a foreign inspection, the investigator completes a written narrative of the inspection, known as an Establishment Inspection Report.
