Consent Decree Update

1
Consent Decree Update

• Cecily Kodis Kaufman
• CBER/OCBQ/DCM
• September 20, 2001

2
Consent Decrees Blood And Blood Products

• American Red Cross
• Blood Systems, Inc.
• New York Blood Center
• Cape Fear Valley Medical Center

3
Consent DecreesPlasma Derivatives

• Alpha Therapeutic Corporation
• Aventis Behring, L.L.C.

4
Consent DecreesIn Vitro Diagnostic Test Kits

• Abbott Laboratories
• Cal-Test Diagnostics

5
Consent Decree ElementsBlood and Blood Products

• Management Controls
• QA/QC
• Computer Systems and Databases
• Records Management
• Systems for HIV Lookback/TAI

6
Consent Decree ElementsBlood and Blood Products
cont

• Donor Suitability Determinations
• Internal Audit System
• Training
• Testing of Blood Products
• Errors and Accidents

7
Consent Decree ElementsPlasma Derivatives

• Training
• Reworked, Reprocessed Returned, Rejected
  Products
• Expert Consultant
• Production and Process Controls

8
Consent Decree ElementsPlasma Derivatives cont

• Laboratory Controls
• Buildings and Facilities
• Equipment
• Recall Procedures

9
American Red Cross

• Entered May 12, 1993
• FY00 One VI.A letter
• 2/00 Inspection of NHQ

10
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

11
Blood Systems, Inc.

• Entered April 22, 1996
• All required documents submitted
• Inspections ongoing
• Internal Audit Summaries

12
New York Blood Center

• Entered December 17, 1996
• All required documents submitted
• Continue to monitor by inspection

13
Cape Fear Valley Medical Center

• Entered November 19, 1993
• All requirements under Decree met
• Consent Decree vacated January 2000

14
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

15
Alpha Therapeutic Corporation,

• Entered February 3, 1998
• Required to cease manufacturing twice
• Submitted required documentation

16
Alpha Therapeutic Corporation continued

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

17
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 IVDs, including certain viral marker
  test kits.

18
Abbott Laboratoriescontinued

• Corrective actions evaluated during inspections
  of the firm
• Continuing to monitor the firms progress

19
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

20
Source Plasma Compliance Rate
21
Blood Compliance Rate