[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: 21CFR20.113]
[Page 216-217]
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. 20.113 Voluntary product defect reports.
Voluntary reports of defects in products subject to the jurisdiction
of the Food and Drug Administration are available for public disclosure:
(a) If the report is submitted by the manufacturer, after deletion
of data and information falling within the exemptions established in
Sec. 20.61 for trade secrets and confidential commercial or
[[Page 217]]
financial information and in Sec. 20.63 for personal privacy.
(b) If the report is submitted by any person other than the
manufacturer, after deletion of names and other information that would
identify the person submitting the report and any data or information
falling within the exemption established in Sec. 20.63 for personal
privacy.
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