FDA Inspection
RegulatoryAlso known as: FDA audit, FDA facility inspection, 483 inspection
An FDA investigator's on-site examination of a manufacturing facility.
What It Means
FDA inspections are on-site examinations of manufacturing facilities by FDA investigators. Inspections can be routine (scheduled), for-cause (triggered by complaints, adverse events, or import alerts), or pre-approval. Findings are documented on FDA Form 483 ('Inspectional Observations'). Serious or uncorrected findings can lead to Warning Letters, import alerts, injunctions, or seizures. FDA inspection history is public record.
What It Is Not
An FDA inspection is NOT FDA approval. A facility can be inspected and receive multiple 483 observations while still operating legally. Conversely, absence of recent FDA inspection does not mean the facility is compliant — FDA cannot inspect all facilities regularly. Companies that highlight 'no 483 observations' may simply not have been inspected recently.
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