Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003.

  • United States. Congress. Senate. Committee on Governmental Affairs.
Date:
2003
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Licence: Public Domain Mark

Credit: Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003. Source: Wellcome Collection.

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    Letter from Senator Susan M. Collins, Ranking Minority Member, Perma- nent Subcommittee on Investigations, to Bernard A. Schwetz, D.V.M., Ph.D., Acting Principal Deputy Commissioner, Food and Drug Adminis- tration (FDA), February 11, 2002, concerning the status of the FDA’s tissue action plan POOR eee HOS e EE EOE EH HEHE EH HEE EE EH EEEESEEE HEHEHE SOOO ESSE ES ESHSEEESEEESHESEEEES ESOS ESSE SES ESES Food and Drug Administration (FDA), to Senator Susan M. Collins, Rank- ing Minority Member, Permanent Subcommittee on Investigations, April 3, 2002, concerning the status of the FDA’s tissue action plan weer eesecscesseseoee nent Subcommittee on Investigations, to The Honorable Tommy G. Thompson, Secretary of Health and Human Services, April 12, 2002, concerning the status of the FDA’s tissue action plan emer ere ereseresseeseseseeseeese and Human Services, to Senator Susan M. Collins, Ranking Minority Member, Permanent Subcommittee on Investigations, August 28, 2002, concerning the status of the FDA’s tissue action plan Seem ee oe ereseeressesessesscessees nation of Mark B. McClellan, to be Commissioner of the Food and Drug Administration, Department of Health and Human Services; U.S. Senate Committee on Health, Education, Labor, and Pensions, October 2002 ....... FDA Notice of Inspectional Observations (Form FDA-483) from Inspec- tion 3/25/2002—4/12/2002 (FEI #3001451326), issued to James C. Vander Wyk, Vice-President of Quality Assurance/Regulatory Affairs, CryoLife Eng: GapodAgril: Ty. 2002 eset oes socce eretousandeces Capen uaneeoagtvaceisacayaiae tea eees Letter from James C. Vander Wyk, Ph.D., Vice-President, Regulatory Affairs and Quality Assurance, CryoLife, Inc., to Mr. Ballard H. Graham, District Director, HFE—SE100, Food and Drug Administration, regarding “Initial reply to Notice of Inspectional Observations (483) from Inspection of 3/25/2002—4/12/2002 (FEI #3001451326), dated May 15, 2002 Sample of Complaint Record, CryoLife, Inc teerececescscossccs SOPOT O SHES HOSES EEE SEE SESE SESE ESOS ES EE EEESSEEEOS Page 101 103 106 109 110 tit