FDA To Pull Immucor's Biologics License

Law360, New York (June 26, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration plans to revoke the biologics license of medical device maker Immucor Inc. in relation to an investigation into some of the company's blood reagents, Immucor revealed Friday.

The notice of intent from the FDA, issued Thursday, is based on the results of an early January FDA inspection, Immucor said, while noting that the agency has not ordered that any of the company's products be recalled. The company has 10 days to respond to the FDA.

“We take our regulatory responsibilities...
To view the full article, register now.