FAILURE OF THE ARC TO MEET REQUIREMENTS YIELDS OVER 9 MILLION DOLLAR FINE
From April through October 2010, United States Food and Drug Administration (FDA) investigators inspected sixteen American National Red Cross (ARC) Blood Services facilities and observed significant violations of the law, regulations, and the Amended Consent Decree of Permanent Injunction, entered on April 15, 2003 (Decree). At the conclusion of each inspection, the investigators issued Forms FDA 483, Inspectional Observations (FDA 483),
The Decree requires ARC to establish and properly implement appropriate quality assurance (QA) and quality control (QC) measures. Proper QA and QC programs by blood establishments include measures to prevent, detect, investigate, evaluate, and correct errors. The goals of these programs include preventing the distribution of unsuitable blood products, and preventing the causes of recurrent problems. The proper implementation of a strong QA program is essential to ensure the safety of the nation’s blood supply.
The FDA during their 2010 inspections found a number of Decree Violations to include:
1) Inadequate managerial Control
2) Inadequate QA
3) Failure to Comply with Reporting Requirements
4) Inadequate Problem Management
5) Failure to Follow SOP
6) Failure to Follow Manufacturer’s Instructions
7) Inadequate Training
8) Inadequate Recordkeeping
Because of these findings, the FDA has determined that ARC did not comply with the law and under paragraph IX is fining the ARC a total of $9,592,000.
Please read the entire Adverse Determination Letter at
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