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Chapter 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:
6-1 - SEIZURE
6-1-1 - Purpose
6-1-2 - General Guidelines For Seizures
6-1-3 - Types Of Seizures
6-1-4 - Recipient of Seizure Recommendations
6-1-5 - Mass Seizure - Special Considerations
6-1-6 - Direct Reference Mass Seizure Authority
6-1-7 - Methods Of Recommending Seizure
6-1-8 - Update Inspections
6-1-9 - Action On Seizure Recommendations
6-1-10 - Seizure Accomplishment And Close-Out Documentation
6-1-11 - Disposition Of Seized Articles
6-1-12 - Costs Of Supervision
6-1-13 - Monitoring Of Seizure Actions
6-1-14 - Seizures Involving Other Agencies
6-1-15 - Issuing Press Releases
6-2 - INJUNCTIONS
6-2-1 - Purpose
6-2-2 - General Guidelines
6-2-3 - Definitions
6-2-4 - General Considerations
6-2-5 - Adequate Notice Preceding Injunction Actions
6-2-6 - Prerequisites For A TRO Or Preliminary Injunction
6-2-7 - Refreshing Evidence - Update Inspections
6-2-8 - Procedures And Timeframes For Review And Referral Of Injunction
6-2-9 - Required Documents
6-2-10 - Injunction Recommendation
6-2-11 - Cover Letter To DoJ
6-2-12 - Complaint For Injunction
6-2-13 - Declarations
6-2-14 - Consent Decree
6-2-15 - Costs Of Supervision
6-2-16 - Compliance Follow-Up
6-2-17 - Vacating Injunctions
6-2-18 - Distribution
6-2-19 - Issuing Press Releases
6-3 - INSPECTION WARRANTS
6-3-1 - Purpose
6-3-2 - Inspection Warrants
6-3-3 - Responsibilities
6-4 - SEARCH WARRANTS
6-4-1 - Purpose
6-4-2 - Search Warrants
6-4-3 - Procedures
6-5 - PROSECUTION
6-5-1 - Purpose
6-5-2 - Office Of Criminal Investigations
6-5-3 - Processing A Summary And Recommendation
6-5-4 - Criminal Prosecution After Section 305 Notice
6-5-5 - Criminal Prosecution Without Section 305 Notice
6-5-6 - Contempt Of Court; Violation Of Probation
6-5-7 - Development of Felony Violation
6-5-8 - Referrals For Criminal Investigation
6-5-9 - Information And Indictments
6-5-10 - Grand Jury Investigations And Secrecy
6-5-11 - Format For Summary & Recommendation
6-5-12 - Preparation Of Summary And Recommendation
6-5-13 - Distribution Of Summary And Recommendation Documents
6-6 - CIVIL PENALTIES - ELECTRONIC PRODUCT RADIATION CONTROL
6-6-1 - Purpose
6-6-2 - Scope
6-6-3 - Legal Authority
6-6-4 - Criteria For Recommending Civil Penalties
6-6-5 - Penalties
6-6-6 - District Responsibilities
6-6-7 - CDRH Responsibilities
6-6-8 - DCMO Responsibilities
6-6-9 - OCC Responsibilities
6-6-10 - Appeals
6-6-11 - Consent Decree Of Civil Penalty
6-6-12 - Case Termination
6-6-13 - Injunction and Civil Penalties
6-7 - EXHIBITS
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