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horizonal rule
Dockets Management


CP 1
Volume 1

Citizen Petition

Exhibit 1 - April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc. (ASI)

Exhibit 2 - Response of ASI and Mr. Fredeking to the April 14, 2003 Warning Letter

Exhibit 3 - IRB Notice of Intent to Disband and Cease Record Retention Letters

Exhibit 4 - North Texas Institutional Review Board Establishment Inspection Report

Exhibit 5 - Notice of Inspection (FD-483) presented on December 17, 2002

Exhibit 6 - The North Texas Institutional Review Board response to FD-483, sent on or about January 22, 2003.

Exhibit 7 - FDA Warning Letter regarding the December 2002 inspection of NTIRB sent to Terry Fredeking, President of ASI.

Exhibit 8 - May 7, 2003 written response to Exhibit 7 submitted to FDA.

Exhibit 9 - August 25, 2003 letter from the District Director of FDA transmitting a copy of the Establishment Inspection Report (EIR) of the IRB to Dr. Dishon of the NTIRB.

Exhibit 10 - Affidavit of Dr. Stewart stating that his employer at all relevant times was UTA, his role on NTIRB, the nature of any relationship with ASI, the fact that his vote was his vote, and that the IRB discontinued operations five years ago.

Exhibit 11 - Warning Letters and Responses home page (http://www.fda.gov/foi/warning.htm) and search results.

Exhibit 12 - December 29, 2003 response by Mr. Fredeking to FDA about the posting of the Warning Letter on FDA’s Web Page.

Exhibit 13 - August 26, 2004 CBER’s Office of Communication response to Exhibit 12

Exhibit 14 - September 15, 2004 ASI response to Exhibit 13

Exhibit 15 - October 5, 2004 response by the Acting Director of CBER Office of Compliance to Exhibit 14.

Exhibit 16 - Affidavit of Dr. Neil Dishon.

Exhibit 17 - Affidavit of Romalee Harris.

Exhibit 18 - Affidavit of Patricia H. Okimi, Ph.D.

Exhibit 19 - Affidavit of Joel Montgomery, Ph.D., M.Sc.

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