[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.101]

[Page 219-220]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 20--PUBLIC INFORMATION--Table of Contents
 
        Subpart F--Availability of Specific Categories of Records
 
Sec. 20.101  Administrative enforcement records.

    (a) All Food and Drug Administration records relating to 
administrative enforcement action disclosed to any member of the public, 
including the person who is the subject of such action, are available 
for public disclosure at the time such disclosure is first made. Such 
records include correspondence with companies following factory 
inspection, recall or detention requests, notice of refusal of admission 
of an imported product, regulatory letters, information letters, Forms 
FD-483 and FD-2275 furnished to companies after factory inspection, and 
similar records.
    (b) To the extent that any of such records fall within the exemption 
for investigatory records established in Sec. 20.64, the Commissioner 
determines that they are subject to discretionary release pursuant to 
Sec. 20.82.

[[Page 220]]

    (c) Records relating to administrative enforcement action that are 
not disclosed to any member of the public constitute investigatory 
records that are subject to the rules for disclosure established in 
Sec. 20.64. For example, an establishment inspection report is an 
investigatory record and thus subject to Sec. 20.64 except insofar as 
the Commissioner exercises his discretion to release it pursuant to 
Sec. 20.82.