[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.120]

[Page 147-148]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 820--QUALITY SYSTEM REGULATION--Table of Contents
 
                Subpart K--Labeling and Packaging Control
 
Sec. 820.120  Device labeling.


    Each manufacturer shall establish and maintain procedures to control 
labeling activities.
    (a) Label integrity. Labels shall be printed and applied so as to 
remain legible and affixed during the customary conditions of 
processing, storage, handling, distribution, and where appropriate use.
    (b) Labeling inspection. Labeling shall not be released for storage 
or use until a designated individual(s) has examined the labeling for 
accuracy including, where applicable, the correct expiration date, 
control number, storage instructions, handling instructions, and any 
additional processing instructions. The release, including the date

[[Page 148]]

and signature of the individual(s) performing the examination, shall be 
documented in the DHR.
    (c) Labeling storage. Each manufacturer shall store labeling in a 
manner that provides proper identification and is designed to prevent 
mixups.
    (d) Labeling operations. Each manufacturer shall control labeling 
and packaging operations to prevent labeling mixups. The label and 
labeling used for each production unit, lot, or batch shall be 
documented in the DHR.
    (e) Control number. Where a control number is required by 
Sec. 820.65, that control number shall be on or shall accompany the 
device through distribution.