[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: 21CFR600.21]

[Page 15]
 
                        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.  600.21  Time of inspection.

    The inspection of an establishment for which a biologics license 
application is pending need not be made until the establishment is in 
operation and is manufacturing the complete product for which a 
biologics license is desired. In case the license is denied following 
inspection for the original license, no reinspection need be made until 
assurance has been received that the faulty conditions which were the 
basis of the denial have been corrected. An inspection of each licensed 
establishment and its additional location(s) shall be made at least once 
every 2 years. Inspections may be made with or without notice, and shall 
be made during regular business hours unless otherwise directed.

[38 FR 32048, Nov. 20, 1973, as amended at 48 FR 26314, June 7, 1983; 64 
FR 56449, Oct. 20, 1999]