FDA's Regulatory Procedures Manual Effective May 2012 Regarding Advisory Actions Such as Warning Letters

Regulatory Procedures Manual – May 2012 Chapter 4 Advisory Actions
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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:
Section Topic  _____Page
4-1 WARNING LETTERS ......................................................................................... 4-2
4-1-1 Warning Letter Procedures................................................................................. 4-2
4-1-2 Warning Letters To Government Agencies......................................................... 4-3
4-1-3 Issuing Warning Letters - Factors to Consider.................................................... 4-4
4-1-4 Center Concurrence And Letters Issued By Centers.......................................... 4-6
4-1-5 Letters For Illegal Promotional Activities........................................................... 4-11
4-1-6 Multiple Center Review..................................................................................... 4-12
4-1-7 Time Frames..................................................................................................... 4-12
4-1-8 Warning Letter Follow-Up ................................................................................. 4-13
4-1-9 Firm Profile Updates in FACTS......................................................................... 4-16
4-1-10 Warning Letter Format...................................................................................... 4-16
4-1-11 Warning Letter Distribution ............................................................................... 4-20
4-1-12 Warning and Untitled Letters Addressed to Importers, Custom Brokers,
and Foreign Firms............................................................................................................ 4-21
4-1-13 Freedom of Information (FOI)........................................................................... 4-22
4-1-14 Center For Biologics Evaluation And Research (CBER)................................... 4-23
4-1-15 Center For Drug Evaluation And Research (CDER)......................................... 4-25
4-1-16 Center For Devices And Radiological Health (CDRH) ...................................... 4-29
4-1-17 Center For Food Safety And Applied Nutrition (CFSAN) and Center for
Veterinary Medicine (CVM).............................................................................................. 4-31
4-1-18 Center for Tobacco Products (CTP) ................................................................. 4-31
4-1-19 Tracking................................................................................................................ 4-32
4-2 UNTITLED LETTERS....................................................................................... 4-33
4-2-1 Policy ................................................................................................................ 4-33
4-2-2 Center Concurrence and Letters Issued By Centers ........................................ 4-33
4-2-3 Tracking ............................................................................................................ 4-34
4-3 USE OF STATE EVIDENCE FOR FDA WARNING LETTERS AND
UNTITLED LETTERS.......................................................................................................... 4-34
4-4 EXHIBITS ......................................................................................................... 4-36Regulatory Procedures Manual – May 2012 Chapter 4 Advisory Actions
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4-1 WARNING LETTERS
4-1-1 Warning Letter Procedures
When it is consistent with the public protection responsibilities of the agency and
depending on the nature of the violation, it is the Food and Drug Administration’s