About FDA
SMG 1121.812
FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF GLOBAL REGULATORY OPERATIONS AND POLICY
OFFICE OF REGULATORY AFFAIRS
OFFICE OF OPERATIONS
OFFICE OF ENFORCEMENT AND IMPORT OPERATIONS
DIVISION OF COMPLIANCE SYSTEMS
Effective Date: 08/07/2012
1. DIVISION OF COMPLIANCE SYSTEMS(DLLRIAB)
A. Serves as subject matter experts on information technology systems built to support compliance and risk based import entry admissibility decisions.
B. Establishes field uniformity for compliance and import activities through adherence to procedural policies for automated systems.
C. Extracts and analyzes data from FDA compliance and import databases to identify and respond to trends of noncompliance and to assist the Agency make informed decisions regarding enforcement/regulatory issues and resource allocation based on risk.
D. Maintains liaison, coordinates, and directs field and Headquarters activities relating to the Government-wide Quality Assurance Program.
E. Serves as the Agency focal point for activities relating to the Federal Medical Products Quality Assurance Program. Maintains liaison with other government agencies procuring medical supplies; issues final administrative approval for quality assurance of specific products and firms.
2. ENFORCEMENT SYSTEMS BRANCH (DLLRIAB1)
A. Serves as subject matter experts on information technology systems built to support compliance actions.
B. Establishes field uniformity for compliance activities through adherence to procedural policies for automated systems.
C. Extracts and analyzes data from FDA compliance databases to identify and respond to trends of noncompliance and to assist the Agency make informed decisions regarding enforcement/regulatory issues and resource allocation based on risk.
D. Manages the Agency's Turbo Establishment Inspection Report (EIR) system.
E. Publishes the FDA Gold Disk and Eureka Disk.
3. IMPORT COMPLIANCE SYSTEMS BRANCH (DLLRIAB2)
A. Serves as subject matter experts on information technology systems built to support import compliance actions.
B. Establishes field uniformity for import activities through adherence to procedural policies for automated systems.
C. Maintains, monitors, periodically evaluates, and modifies when appropriate, electronic screening criteria that assist the Agency, in part, to make risk based import entry admissibility decisions and better target import field exams and sampling at the borders.
D. Extracts and analyzes data from FDA import databases to identify and respond to trends of noncompliance and to assist the Agency make informed decisions regarding enforcement/regulatory issues and resource allocation based on risk.
4. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Office were approved by the Commissioner of Food and Drugs on August 7, 2012.
