[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: 21CFR7.53]
[Page 72]
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. 7.53 Recall status reports.
(a) The recalling firm is requested to submit periodic recall status
reports to the appropriate Food and Drug Administration district office
so that the agency may assess the progress of the recall. The frequency
of such reports will be determined by the relative urgency of the recall
and will be specified by the Food and Drug Administration in each recall
case; generally the reporting interval will be between 2 and 4 weeks.
(b) Unless otherwise specified or inappropriate in a given recall
case, the recall status report should contain the following information:
(1) Number of consignees notified of the recall, and date and method
of notification.
(2) Number of consignees responding to the recall communication and
quatity of products on hand at the time it was received.
(3) Number of consignees that did not respond (if needed, the
identity of nonresponding consignees may be requested by the Food and
Drug Administration).
(4) Number of products returned or corrected by each consignee
contacted and the quantity of products accounted for.
(5) Number and results of effectiveness checks that were made.
(6) Estimated time frames for completion of the recall.
(c) Recall status reports are to be discontinued when the recall is
terminated by the Food and Drug Administration.
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