[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.22]

[Page 15-16]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 600_BIOLOGICAL PRODUCTS: GENERAL--Table of Contents
 
                   Subpart C_Establishment Inspection
 
Sec.  600.22  Duties of inspector.

    The inspector shall:
    (a) Call upon the active head of the establishment, stating the 
object of his visit,
    (b) Interrogate the proprietor or other personnel of the 
establishment as he may deem necessary,
    (c) Examine the details of location, construction, equipment and 
maintenance, including stables, barns, warehouses, manufacturing 
laboratories, bleeding clinics maintained for the collection of human 
blood, shipping rooms, record rooms, and any other structure or 
appliance used in any part of the manufacture of a product,

[[Page 16]]

    (d) Investigate as fully as he deems necessary the methods of 
propagation, processing, testing, storing, dispensing, recording, or 
other details of manufacture and distribution of each licensed product, 
or product for which a license has been requested, including observation 
of these procedures in actual operation,
    (e) Obtain and cause to be sent to the Director, Center for 
Biologics Evaluation and Research or the Director, Center for Drug 
Evaluation and Research (see mailing addresses in Sec.  600.2), adequate 
samples for the examination of any product or ingredient used in its 
manufacture,
    (f) Bring to the attention of the manufacturer any fault observed in 
the course of inspection in location, construction, manufacturing 
methods, or administration of a licensed establishment which might lead 
to impairment of a product,
    (g) Inspect and copy, as circumstances may require, any records 
required to be kept pursuant to Sec.  600.12,
    (h) Certify as to the condition of the establishment and of the 
manufacturing methods followed and make recommendations as to action 
deemed appropriate with respect to any application for license or any 
license previously issued.

[38 FR 32048, Nov. 20, 1973, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11013, Mar. 26, 1990; 70 FR 14982, Mar. 24, 2005]