AEGiS-WSJ: FDA Finds Violations at Red Cross Exposing Blood Supply to Safety Risks

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

FDA Finds Violations at Red Cross Exposing Blood Supply to Safety Risks

Wall Street Journal - December 4, 2000
By a Wall Street Journal Staff Reporter

WASHINGTON -- Despite years of close government scrutiny, errors and procedural lapses at the American Red Cross continue to leave the nation's blood supply open to safety problems, the Food and Drug Administration said.

FDA inspectors who visited Red Cross headquarters in April found violations of manufacturing standards, such as a quarantine system that doesn't prevent "unsuitable" blood from being released and failure to follow instructions for HIV tests. Findings appeared in briefs filed by the FDA in U.S. District Court in Washington last week.

Since 1993, the Red Cross has been under a consent decree with the FDA, and during that time, the FDA has sent the Red Cross 10 letters on problems found in inspections. The FDA wanted to amend the decree so it could fine the Red Cross for further violations. But the Red Cross asked the court for a mediator. The latest FDA filing contends that such a step isn't "a productive use of its time or resources."

Bernadine Healy, executive director of the Red Cross, said she was "shocked" when told of the violations. The Red Cross has begun borrowing $100 million to make improvements, she said.
001204
WJ001204

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Elton John AIDS Foundation UK, the National Library of Medicine, AIDS Walk of Orange County, and donations from users like you.

Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .