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Consent Decree
Consent Decrees are formal legal agreements between a company and the FDA which commits the company to an extensive review of their CGMP quality systems and subsequent corrective actions. Consent decrees are voluntary but represent the final step after repeated violations or first time significant findings of lack of compliance with CGMPs by FDA. Consent decrees are completely avoidable and should be avoided at all cost- because they cost a tremendous amount to correct. Companies under consent decree may fail to recover from the financial impact of the action. No company who has ever received a consent decree has been released from it.
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