SMG 1262.61

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF COMPLIANCE

OFFICE OF DRUG SECURITY, INTEGRITY AND RECALLS

DIVISION OF IMPORT OPERATIONS AND RECALLS

Effective Date: 07/08/2011

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1. DIVISION OF IMPORT OPERATIONS AND RECALLS (DKKNDFA)

A. Coordinates evaluation and classification of drug recalls and provides Center coordination with field offices for implementation of recalls, and monitors resolution, and coordinates expert input into related compliance issues

B. Reduces consumer exposure to unsafe, ineffective, and poor quality imported drugs, by assuring compliance with applicable legal requirements

C. Provides CDER support and guidance for drug import operations

D. Ensures quality and integrity of exported drugs by providing guidance and consults on export policies and procedures

2. RECALLS COORDINATION BRANCH (DKKNDFDA1)

A. Coordinates potential recalls and prompt follow-up activities by including all relevant agency units, including field offices

B. Obtains technical evaluations on adulteration issues from Office of Manufacturing and Product Quality, and misbranding violations from the Office of Unapproved Drugs and Labeling Compliance

C. Convenes committee of experts to create consensus on classification of significant drug recalls, and assures endorsements of involved organizational units

D. Provides risk communication on pending or completed recalls to internal and external stakeholders

E. Reviews and develops legislative proposals and implementing regulations, policy and guidance documents, enforcement strategies, and outreach activities related to drug recalls

3. IMPORT OPERATIONS BRANCH (DKKNDFA2)

A. Serves as FDA focal point for all operational compliance issues related to imported and exported drugs

B. Consults and provides guidance to the field on import programs and operations for drugs. Assists in ensuring consistent and strategic import activities and compliance programs

C. Provides assistance and guidance to the field and consults on import issues and problems related to specific products offered for import

D. Coordinates with ORA on policies and programs related to import operations

E. Reviews and issues, when appropriate, export certificates

F. Develops and provides guidance on export policies and procedures

4. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	05/20/2011	N/a	CDER/OM	Commissioner of Food and Drugs
Revision	07/08/2011	N/a	CDER/OM	Secretary of the Department of Health and Human Services