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

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 DecreesPlasma Derivatives

• Alpha Therapeutic Corporation

• Aventis Behring, L.L.C.

Consent DecreesIn Vitro Diagnostic Test Kits

• Abbott Laboratories

• Cal-Test Diagnostics

Consent Decree ElementsBlood and Blood Products

• Management Controls

• QA/QC

• Computer Systems and Databases

• Records Management• Systems for HIV Lookback/TAI

Consent Decree ElementsBlood and Blood Products

cont…• Donor Suitability Determinations

• Internal Audit System

• Training

• Testing of Blood Products• Errors and Accidents

Consent Decree ElementsPlasma Derivatives

• Training

• Reworked, Reprocessed Returned, Rejected Products

• Expert Consultant

• Production and Process Controls

Consent Decree ElementsPlasma 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 Crosscontinued

• 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 2001 -findings under review

• Firm continues to distribute Albumin and medically necessary products with 3rd 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 Laboratoriescontinued

• 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

97.1

91.7

93.2 93.6 94

97.296 96.4

89.5

96.4

94.6

84

86

88

90

92

94

96

98

Per

cent

90 91 92 93 94 95 96 97 98 99 2000

Fiscal Year

97.3

96.6

95.6

97.5

93.4

95.996.4 96.4

97.7 97.7 97.7

91

92

93

94

95

96

97

98

Per

cent

90 91 92 93 94 95 96 97 98 99 2000

Fiscal Year

Blood Compliance Rate