[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.45]
[Page 70]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 7 ENFORCEMENT POLICY--Table of Contents
Subpart C Recalls (Including Product Corrections) Guidance on Policy,
Procedures, and Industry Responsibilities
Sec. 7.45 Food and Drug Administration-requested recall.
(a) The Commissioner of Food and Drugs or designee may request a
firm to initiate a recall when the following determinations have been
made:
(1) That a product that has been distributed presents a risk of
illness or injury or gross consumer deception.
(2) That the firm has not initiated a recall of the product.
(3) That an agency action is necessary to protect the public health
and welfare.
(b) The Commissioner or his designee will notify the firm of this
determination and of the need to begin immediately a recall of the
product. Such notification will be by letter or telegram to a
responsible official of the firm, but may be preceded by oral
communication or by a visit from an authorized representative of the
local Food and Drug Administration district office, with formal, written
confirmation from the Commissioner or his designee afterward. The
notification will specify the violation, the health hazard
classification of the violative product, the recall strategy, and other
appropriate instructions for conducting the recall.
(c) Upon receipt of a request to recall, the firm may be asked to
provide the Food and Drug Administration any or all of the information
listed in Sec. 7.46(a). The firm, upon agreeing to the recall request,
may also provide other information relevant to the agency's
determination of the need for the recall or how the recall should be
conducted.
[43 FR 26218, June 16, 1978, as amended at 69 FR 17290, Apr. 2, 2004]
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