FDA Form 482, Notice of Inspection, is issued by FDA investigators to formally notify a site or organization that an FDA inspection is being initiated.
It authorizes review of facilities, records, and processes related to regulated activities, including clinical trial conduct. In clinical research, receiving an FDA-482 signals that documentation, source records, and oversight evidence may be reviewed for compliance and data integrity. Sites and sponsors must respond promptly and provide requested materials in an organized, traceable manner. Proper preparation supports efficient inspection management and reduces compliance risk.