Inspections, Compliance, Enforcement, and Criminal Investigations
Ch. 5 - Administrative Actions
NOTE: The district compliance officer (or, the center CSO/Scientist, if the action was center-initiated) assigned to the administrative action should diligently pursue and actively monitor the progress of the case through the Agency review process to its conclusion. The Office of Enforcement and Import Operations (OEIO), (Division of Enforcement) 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.
5-1 - CITATIONS 5-2 - SECTION 305 MEETING 5-3 - ADMINISTRATIVE DETENTION OF FOODS 5-4 - DETENTION OF FOODS - OTHER STATUTORY AUTHORITY 5-5 - ADMINISTRATIVE DETENTION OF DEVICES 5-6 - LICENSE REVOCATION OR SUSPENSION 5-7 - ORDERS OF RETENTION, RECALL, DESTRUCTION AND CESSATION OF MANUFACTURING RELATED TO HUMAN CELL, TISSUE AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) 5-8 - CIVIL MONEY PENALTIES AND NO-TOBACCO-SALE ORDERS 5-9 - DISQUALIFICATION OF CLINICAL INVESTIGATORS 5-10 - EXHIBITS