[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.101]
[Page 212]
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.
(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.
Back to Top
© 2007 Betterchem Corp.
|
