[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR812.145]



[Page 114]

 

                        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 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.