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Consent Decree |
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If a firm has repeatedly violated cGMP requirements, the FDA may make a
legal agreement with the firm to force them to make specific changes;
the agreement, the consent decree, is enforced by the federal courts.
Usually, consent decrees include fines ("disgorgements"),
reimbursements to the government for inspection costs, due dates for
specific actions, and penalties for noncompliance. Consent decrees
usually are permanent, but at times specified in the agreement when the
firm has achieved compliance, it can petition the court to remove the
decree. (Of the more than 25 consent decrees issued between 1990 and
2003, only one or two firms have been removed from their decrees.)
For example, Schering-Plough entered into this consent decree. |
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