[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.145]

[Page 119-120]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
                      Subpart G_Records and Reports
 
Sec.  812.145  Inspections.

    (a) Entry and inspection. A sponsor or an investigator who has 
authority to grant access shall permit authorized FDA employees, at 
reasonable times and in a reasonable manner, to enter and inspect any 
establishment where devices are held (including any establishment where 
devices are manufactured, processed, packed, installed, used, or 
implanted or where records of results from use of devices are kept).
    (b) Records inspection. A sponsor, IRB, or investigator, or any 
other person acting on behalf of such a person with

[[Page 120]]

respect to an investigation, shall permit authorized FDA employees, at 
reasonable times and in a reasonable manner, to inspect and copy all 
records relating to an investigation.
    (c) Records identifying subjects. An investigator shall permit 
authorized FDA employees to inspect and copy records that identify 
subjects, upon notice that FDA has reason to suspect that adequate 
informed consent was not obtained, or that reports required to be 
submitted by the investigator to the sponsor or IRB have not been 
submitted or are incomplete, inaccurate, false, or misleading.