[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: 21CFR822.35]

[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. 822.35  Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?

    We can review your postmarket surveillance programs during regularly 
scheduled inspections, inspections initiated to investigate recalls or 
other similar actions, and inspections initiated specifically to review 
your postmarket surveillance plan. We may also inspect any other person 
or site involved in your postmarket surveillance, such as investigators 
or contractors. Any person authorized to grant access to a facility must 
permit authorized FDA employees to enter and inspect any facility where 
the device is held or where records regarding postmarket surveillance 
are held.