[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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.