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Compliance References
Regulatory Procedures Manual 2008
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Chapter 4 Advisory Actions

This chapter defines and establishes uniform guidance and procedures for Warning Letters and Untitled Letters.

This chapter includes the following sections:

4-1 - WARNING LETTERS
     4-1-1 - Warning Letter Procedures
     4-1-2 - Warning Letters To Government Agencies
     4-1-3 - Issuing Warning Letters - Factors to Consider
     4-1-4 - Center Concurrence And Letters Issued By Centers
     4-1-5 - Letters For Illegal Promotional Activities
     4-1-6 - Multiple Center Review
     4-1-7 - Time Frames
     4-1-8 - Warning Letter Follow-Up
     4-1-9 - Firm Profile Updates in FACTS
     4-1-10 - Warning Letter Format
     4-1-11 - Warning Letter Distribution
     4-1-12 - Warning and Untitled Letters Addressed to Importers, Customs Brokers, and Foreign Firms
     4-1-13 - Freedom of Information (FOI)
     4-1-14 - Center For Biologics Evaluation And Research (CBER)
     4-1-15 - Center For Drug Evaluation And Research (CDER)
     4-1-16 - Center For Devices And Radiological Health (CDRH)
     4-1-17 - Center For Food Safety And Applied Nutrition (CFSAN)
     4-1-18 - Tracking
4-2 - UNTITLED LETTERS
     4-2-1 - Policy
     4-2-2 - Tracking
4-3 - EXHIBIT
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