[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR822.36]

[Page 164]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 822--POSTMARKET SURVEILLANCE--Table of Contents
 
                     Subpart G--Records and Reports
 
Sec. 822.36  Can you inspect and copy the records related to my postmarket surveillance plan?

    We may, at a reasonable time and in a reasonable manner, inspect and 
copy any records pertaining to the conduct of postmarket surveillance 
that are required to be kept by this regulation. You must be able to 
produce records and information required by this regulation that are in 
the possession of others under contract with you to conduct the 
postmarket surveillance. Those who have signed agreements or are under 
contract with you must also produce the records and information upon our 
request. This information must be produced within 72 hours of the 
initiation of the inspection. We generally will redact information 
pertaining to individual subjects prior to copying those records, unless 
there are extenuating circumstances.