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U.S. Department of Health and Human Services

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SMG 1262.6

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

Effective Date: 07/08/2011

[PDF Version]

1. OFFICE OF DRUG SECURITY, INTEGRITY AND RECALLS (DKKNDF)

A. Develops policies and compliance strategies for protecting the public health by assuring drug product integrity and supply chain security

B. Coordinates evaluation and classification of drug recalls and provides Center coordination with field offices for implementation of recalls and monitors resolution of related compliance issues

C. Ensures integrity of imported drug products by assuring compliance with applicable legal requirements

2. AUTHORITY AND EFFECTIVE DATE

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

STATUS
(I, R, C)		DATE APPROVEDLOCATION
OF CHANGE HISTORY		CONTACTAPPROVING OFFICIAL
Initial05/20/2011N/aCDER/OMCommissioner of Food and Drugs
Revision07/08/2011N/aCDER/OMSecretary of the Department
of Health and Human Services

 

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