Consent Decree Update Cecily Kodis Kaufman CBER/OCBQ/DCM September 20, 2001

Consent Decrees Blood And Blood Products American Red Cross Blood Systems, Inc. New York Blood Center Cape Fear Valley Medical Center

Consent Decrees Plasma Derivatives Alpha Therapeutic Corporation Aventis Behring, L.L.C.

Consent Decrees In Vitro Diagnostic Test Kits Abbott Laboratories Cal-Test Diagnostics

Consent Decree Elements Blood and Blood Products Management Controls QA/QC Computer Systems and Databases Records Management Systems for HIV Lookback/TAI

Consent Decree Elements Blood and Blood Products cont… Donor Suitability Determinations Internal Audit System Training Testing of Blood Products Errors and Accidents

Consent Decree Elements Plasma Derivatives Training Reworked, Reprocessed Returned, Rejected Products Expert Consultant Production and Process Controls

Consent Decree Elements Plasma Derivatives cont… Laboratory Controls Buildings and Facilities Equipment Recall Procedures

American Red Cross Entered May 12, 1993 FY00 – One VI.A letter 2/00 – Inspection of NHQ

American Red Cross continued No manufacturing errors resulting in shipment of products reactive for viral markers FDA and ARC working toward compliance goals Continuing to inspect and enforce CD

Blood Systems, Inc. Entered April 22, 1996 All required documents submitted Inspections ongoing Internal Audit Summaries

New York Blood Center Entered December 17, 1996 All required documents submitted Continue to monitor by inspection

Cape Fear Valley Medical Center Entered November 19, 1993 All requirements under Decree met Consent Decree vacated January 2000

Aventis Behring, L.L.C. Formerly Centeon, L.L.C. Entered January 28, 1997 Inspection April/May findings under review Firm continues to distribute Albumin and medically necessary products with 3 rd party controls

Alpha Therapeutic Corporation, Entered February 3, 1998 Required to cease manufacturing twice Submitted required documentation

Alpha Therapeutic Corporation continued FDA inspected firm April-May 2001 June 26, 2001 Alpha resumed manufacturing and distribution of all products

Abbott Laboratories Entered November 2, 1999 CD requires firm to bring IVD manufacturing processes and CAPA system into compliance Allowed to continue distribution of medically necessary IVD’s, including certain viral marker test kits.

Abbott Laboratories continued Corrective actions evaluated during inspections of the firm Continuing to monitor the firms progress

Cal Test Diagnostics Entered June 15, 2000 Sold diagnostic test kits without premarket approval and failed to conform to CGMP Destroyed all devices, components and labeling material

Source Plasma Compliance Rate

Blood Compliance Rate