[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: 21CFR1.361]

[Page 43]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents
 
    Subpart J_Establishment, Maintenance, and Availability of Records
 
Sec.  1.361  What are the record availability requirements?

    When FDA has a reasonable belief that an article of food is 
adulterated and presents a threat of serious adverse health consequences 
or death to humans or animals, any records and other information 
accessible to FDA under section 414 or 704(a) of the act (21 U.S.C. 350c 
and 374(a)) must be made readily available for inspection and 
photocopying or other means of reproduction. Such records and other 
information must be made available as soon as possible, not to exceed 24 
hours from the time of receipt of the official request, from an officer 
or employee duly designated by the Secretary of Health and Human 
Services who presents appropriate credentials and a written notice.