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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ch. 6 - Judicial Actions

NOTE: The district compliance officer (or, the center CSO/Scientist, if the action was center-initiated) assigned to the judicial action should diligently pursue and actively monitor the progress of the case through the agency review process to its conclusion. The Office of Enforcement (Division of Compliance Management and Operations) can assist in situations where significant delays are experienced or assistance is needed to resolve technical, scientific, or policy issues. (Also, see section on Ad Hoc Committees in Chapter 10.) For actions resulting from a Current Good Manufacturing Practice (CGMP) or Quality System (QS) inspection of a domestic or foreign drug, biologics, or medical device facility, the firm’s profile status information in the Field Accomplishment and Compliance Tracking System (FACTS) should be appropriately updated at each stage in the review process.   (See "Firm Profile Updates in FACTS" in Chapter 4 for more information.)

This chapter contains the following sections: