University of Illinois @ Urbana - Champaign (Sponsor), Champaign, Illinois, 01/29, 30 & 31/2003, FDA Inspectional Observations
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 letter is available in PDF at the bottom of this page.
DISTRICT OFFICE ADDRESS AND PHONE NUMBER
550 W. Jackson Blvd.
Chicago, IL 60661
DATE(S) OF INSPECTION
01/29, 30 & 31/2003
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Melanie J. Loots, Associate Vice Chancelor
University of Illinois @ Urbana-Champaign
601 E. St. John Street, 400 Swanland MC-304
CITY, STATE AND ZIP CODE
Champaign, Illinois 61820
TYPE OF ESTABLISHMENT INSPECTED
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) NAME AND TITLE (Print or Type)
Mark G. Peterson, Investigator
Amey L. Adams, Biologist
Michele C. McGuinness
EMPLOYEE(S) SIGNATURE [Handwritten Signatures]
Mark G. Peterson
Amey L. Adams
Michele C. McGuinness
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