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Consent Decrees

US-unique

Consent decrees and other federal court-ordered injunctions are a US-specific FDA enforcement tool. There is no direct equivalent in EU, Australian, or Canadian medical device regulation.

A consent decree of permanent injunction is a court order — agreed between FDA and a company — requiring the company to:

  • Cease specific violative manufacturing operations
  • Implement a remediation programme under expert oversight
  • Obtain third-party certification before resuming manufacturing
  • Pay penalties for future violations

Consent decrees typically follow a pattern of repeated QMSR violations, inadequate responses to warning letters, and failure to voluntarily correct manufacturing deficiencies.

  1. Inspections identify QMSR violations
  2. FDA issues 483 observations
  3. Manufacturer's response is inadequate
  4. FDA issues a Warning Letter
  5. Manufacturer fails to adequately correct or continues violating
  6. DOJ files for injunction on behalf of FDA
  7. Company agrees to consent decree (or court imposes injunction after trial)

Companies under consent decrees typically must:

  • Halt manufacturing of violative products
  • Engage an FDA-approved independent expert (third-party auditor/consultant)
  • Submit a remediation plan to FDA for approval
  • Achieve expert certification before resuming manufacturing
  • Maintain ongoing third-party oversight
  • Pay substantial civil penalties for future violations

Official resources​