[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: 21CFR7.59]
[Page 73]
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. 7.59 General industry guidance.
A recall can be disruptive of a firm's operation and business, but
there are several steps a prudent firm can take in advance to minimize
this disruptive effect. Notwithstanding similar specific requirements
for certain products in other parts of this chapter, the following is
provided by the Food and Drug Administration as guidance for a firm's
consideration:
(a) Prepare and maintain a current written contingency plan for use
in initiating and effecting a recall in accordance with Sec. Sec. 7.40
through 7.49, 7.53, and 7.55.
(b) Use sufficient coding of regulated products to make possible
positive lot identification and to facilitate effective recall of all
violative lots.
(c) Maintain such product distribution records as are necessary to
facilitate location of products that are being recalled. Such records
should be maintained for a period of time that exceeds the shelf life
and expected use of the product and is at least the length of time
specified in other applicable regulations concerning records retention.
Subpart D [Reserved]
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