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.

Each entry in the Database reflects the result of an inspected Project Area. Several Project Areas may be inspected during a single inspection. For more information on the classification of inspections please see the Establishment Inspection Report (EIR) ORA Field Management Directive 86.

The Inspections Database is dynamic and is updated on a regularly recurring basis. Firms’ operations and compliance history can change over time and it may be important to recheck the compliance status of a firm in to order to have the most current information.

Page Last Updated: 11/28/2017
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