consent decree update cecily kodis kaufman cber/ocbq/dcm september 20, 2001
TRANSCRIPT
Consent Decrees Blood And Blood Products
• American Red Cross
• Blood Systems, Inc.
• New York Blood Center
• Cape Fear Valley Medical Center
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 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