FDA Sends Letter to Immucor – Products Used by Blood Banks for Testing Before Transfusions Questioned
Posted Jun 28 2009 9:43pm
The notice puts their biologics license at risk of being revoked and would cost the company about 25% of their business. As the article posts there’ some potential other items being discussed here outside of just the product with the FTC involved, but we want good blood screening by all means too. A year ago the FDA was threatening Red Cross with their issues:
June 26 (Bloomberg) -- Immucor Inc., maker of products used to screen donated blood, fell the most in two months in Nasdaq trading after saying the Food and Drug Administration intends to revoke its biologics license because of manufacturing lapses.
The FDA sent a notice of intent based on a U.S. inspection in January that found “deficiencies” Immucor didn’t specify, the Norcross, Georgia-based company said today in a statement. Without the license, Immucor would be unable to sell its reagent red blood cells and anti-e blood grouping reagent in the U.S. and would lose about 25 percent of its revenue, said Joshua Zable, a Natixis Bleichroeder analyst in New York.
Immucor’s reagents are used by hospital blood banks, labs and blood donation centers to test for blood type and antibodies before transfusions . The U.S. Justice Department is investigating possible criminal violations in the blood reagents industry and has requested documents dating to 2000, Immucor said in April. The Federal Trade Commission has been conducting an antitrust probe involving Immucor since 2007, the company said.