Note: Although this FDA-483 is an
accurate representation of the original FDA-483 issued to the firm, it is not an exact
copy. Slight modifications to the original FDA-483 have been made to accommodate its
conversion to the HTML format. A scanned copy of the original FDA-483 is available in PDF format on this website. |
DEPARTMENT OF
HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION |
DISTRICT OFFICE ADDRESS AND PHONE NUMBER
550 W. Jackson Blvd.
Suite 1500
Chicago, IL 60661
(312)353-5863 |
DATE(S) OF INSPECTION
01/29, 30 & 31/2003 |
FEI NUMBER |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Melanie J. Loots, Associate Vice Chancelor |
FIRM
NAME
University of Illinois @ Urbana-Champaign |
STREET
ADDRESS
601 E. St. John Street, 400 Swanland MC-304 |
CITY,
STATE AND ZIP CODE
Champaign, Illinois 61820 |
TYPE OF
ESTABLISHMENT INSPECTED
Sponsor |
DURING
AN INSPECTION OF YOUR FIRM, WE OBSERVED: Failure to adequately monitor INADs
submitted to FDA/CVM as follows:
- In the role of sponsor submitting INAD [redacted] to the U.S. Food and Drug
Administration, the university has not reviewed the protocol used by their Investigator in
this study.
- In the role of sponsor submitting INAD [redacted] to the U.S. Food and Drug
Administration, the university has repeatedly failed to adequately monitor related
research to assure the investigator complied with government regulations and the study
protocol. This deficiency has resulted in the following:
- Sale of 386 investigational hogs for slaughter for food since April 2001 without prior
authorization from FDA.
- Unauthorized rendering of a pig subject to INAD [redacted] on or about 9/27/2002.
|
SEE REVERSE OF THIS PAGE |
EMPLOYEE(S) SIGNATURE
[Handwritten Signatures]
Mark G. Peterson
Amey L. Adams
Michele C. McGuinness |
EMPLOYEE(S)
NAME AND TITLE (Print or Type)
Mark G. Peterson, Investigator
Amey L. Adams, Biologist
Michele C. McGuinness |
DATE ISSUED
1-31-2003 |
FORM FDA 483 (8/00) PREVIOUS EDITION OBSOLETE INSPECTIONAL
OBSERVATIONS
Reverse Text on Page: The observations of objectional conditions and practices listed
on the front of this form are reported:
- Pursuant to Section 704(b) of the Federal Food, Drug and
Cosmetic Act, or
- To assist firms inspected in complying with the Acts and
regulations enforced by the Food and Drug Administration.
|
Section 704(b) of the Federal Food, Drug, and Cosmetic
Act (21 USC374(b)) provides: "Upon
completion of any such inspection of a factory, warehouse, consulting laboratory, or other
establishment, and prior to leaving the premises, the officer or employee making the
inspection shall give to the owner, operator, or agent in charge a report in writing
setting forth any conditions or practices observed by him which, in his judgement,
indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole
or in part of any filthy, putrid, or decomposed substance or (2) has been prepared,
packed, or held under insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. A copy of such report
shall be sent promptly to the Secretary." |
Web page created by ORA Web Team 12/20/2002
|