Inspections, Compliance, Enforcement, and Criminal Investigations
Inspection Classification Definitions
At the end of an inspection, observations made during an inspection are shared with the most responsible party at the firm in an FDA Form 483, Report of Observations. The determination of whether any condition or practice is violative is an Agency decision, made considering all inspectional and compliance input. An inspection classification may be subject to change during Agency review and these changes are reflected in the Inspections Database.