[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR822.37]

[Page 173]
 
                        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. 822.37  Under what circumstances would you inspect records 
identifying subjects?

    We can inspect and copy records identifying subjects under the same 
circumstances that we can inspect any records relating to postmarket 
surveillance. We are likely to be interested in such records if we have 
reason to believe that required reports have not been submitted, or are 
incomplete, inaccurate, false, or misleading.