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
(FDA's) practice to give individuals and firms an opportunity to take voluntary and
prompt corrective action before it initiates an enforcement action. Warning Letters
are issued to achieve voluntary compliance and to establish prior notice. (Prior
notice is discussed in Chapter 10.) The use of Warning Letters and the prior notice
policy are based on the expectation that most individuals and firms will voluntarily
comply with the law.
The agency position is that Warning Letters are issued only for violations of
regulatory significance. Significant violations are those violations that may lead to
enforcement action if not promptly and adequately corrected. A Warning Letter is
the agency's principal means of achieving prompt voluntary compliance with the
Federal Food, Drug, and Cosmetic Act (the Act).
The Warning Letter was developed to correct violations of the statutes or
regulations. Also available to the agency are enforcement strategies which are
based on the particular set of circumstances at hand and may include sequential or
concurrent FDA enforcement actions such as recall, seizure, injunction,
administrative detention, civil money penalties and/or prosecution to achieve
correction. Despite the significance of the violations, there are some circumstances
that may preclude the agency from taking any further enforcement action following
the issuance of a Warning Letter. For example, the violation may be serious
enough to warrant a Warning Letter and subsequent seizure; however, if the
seizable quantity fails to meet the agency's threshold value for seizures, the
agency may choose not to pursue a seizure. In this instance, the Warning Letter
would document prior warning if adequate corrections are not made and
enforcement action is warranted at a later time.
Responsible officials in positions of authority in regulated firms have a legal duty to
implement whatever measures are necessary to ensure that their products,
practices, processes, or other activities comply with the law. Under the law such
individuals are presumed to be fully aware of their responsibilities. Consequently,
responsible individuals should not assume that they would receive a Warning
Letter, or other prior notice, before FDA initiates enforcement action.
FDA is under no legal obligation to warn individuals or firms that they or their
products are in violation of the law before taking enforcement action, except in a
few specifically defined areas. When acting under the authority of Subchapter C -
Electronic Product Radiation Control (formerly the Radiation Control for Health and
Safety Act of 1968) of Chapter V of the Act, FDA is required by law to provide a
written notification to manufacturers when the agency discovers products that fail to
comply with a performance standard or that contain a radiation safety defect.
Because of the legal requirements of Subchapter C, minor variations in the
procedures may occur.Regulatory Procedures Manual – May 2012 Chapter 4 Advisory Actions
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A Warning Letter is informal and advisory. It communicates the agency's position
on a matter, but it does not commit FDA to taking enforcement action. For these
reasons, FDA does not consider Warning Letters to be final agency action on
which it can be sued.
There are instances when issuing a Warning Letter is not appropriate, and, as
previously stated, a Warning Letter is not a prerequisite to taking enforcement
action. Examples of situations where the agency will take enforcement action
without necessarily issuing a Warning Letter include:
1. The violation reflects a history of repeated or continual conduct of a similar
or substantially similar nature during which time the individual and/or firm
has been notified of a similar or substantially similar violation;
2. The violation is intentional or flagrant;
3. The violation presents a reasonable possibility of injury or death;
4. The violations, under Title 18 U.S.C. 1001, are intentional and willful acts
that once having occurred cannot be retracted. Also, such a felony violation
does not require prior notice. Therefore, Title 18 U.S.C. 1001 violations are
not suitable for inclusion in Warning Letters; and,
5. When adequate notice has been given by other means and the violations
have not been corrected, or are continuing. See Chapter 10, Prior Notice, for
other methods of establishing prior notice.
In certain situations, the agency may also take other actions as an alternative to, or
concurrently with, the issuance of a Warning Letter. For example:
1. The product is adulterated under Section 402(a)(3) or 402(a)(4) of the Act;
2. There is a violation of CGMP;
3. The product contains illegal pesticide residues; or
4. The product shows short contents, subpotency, or superpotency.
Additional instructions for Warning Letters in specific product areas are found in
compliance program guidance and in compliance policy guides.
Also, see Exhibit 4-1, the agency’s “Procedures for Clearing FDA Warning Letters
and Untitled Letters.” All agency components responsible for issuing Warning
Letters and Untitled Letters must follow these procedures. Developed to facilitate
review of all Warning Letters and Untitled Letters by the Office of Chief Counsel
(OCC), the procedures provide instructions for submitting such letters to OCC, and
include timeframes and routing information.
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