Consent Decree
What is Consent Decree?
A legally binding agreement between FDA and a company, typically requiring specific corrective actions under court supervision.
Why does Consent Decree matter?
A consent decree is the nuclear option in FDA enforcement. It's a federal court order — agreed to by the company — that dictates exactly what the company must do to return to compliance.
Consent decrees typically follow repeated Warning Letters or egregious violations. They can shut down manufacturing lines, require third-party audits, mandate specific investments, and impose financial penalties.
Companies under consent decree operate under court supervision, sometimes for years. Every batch may require third-party testing. Every change needs FDA approval. The cost of compliance under a consent decree can run into hundreds of millions.
Notable consent decrees: Abbott Laboratories (infant formula, 2023), Ranbaxy (generic drugs, 2012), Johnson & Johnson (hip implants, 2013).
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