enforcement database

FDA Enforcement by Type

Every FDA enforcement action Argus tracks, grouped by the 10 highest-volume action types across recalls, inspection citations, and approvals. Each page lists the most recent actions with direct links to the full record.

• Medical Device Recalls

  2,943 actions on record·FDA recalls of medical devices, from Class I (reasonable probability of serious injury or death) through Class III.

• Drug Recalls

  379 actions on record·FDA recalls of pharmaceutical products, including OTC and prescription drugs.

• Form 483 Inspection Citations

  176 actions on record·FDA Form 483 observations issued after a facility inspection, before any warning letter or recall follows.

• ANDA Approvals

  80 actions on record·Abbreviated New Drug Application approvals -- generic drug approvals granted by the FDA.

• cGMP Warning Letters

  59 actions on record·Warning letters citing current Good Manufacturing Practice violations.

• General Warning Letters

  45 actions on record·FDA warning letters not otherwise categorized by a more specific violation type.

• Unapproved Drug Warning Letters

  33 actions on record·Warning letters citing marketing of a drug without required FDA approval.

• Labeling Violation Warning Letters

  26 actions on record·Warning letters citing misbranding or labeling violations.

• Tobacco Enforcement

  24 actions on record·FDA Center for Tobacco Products warning letters, largely youth-access and marketing violations.

• NDA Approvals

  14 actions on record·New Drug Application approvals -- novel (branded) drug approvals granted by the FDA.