UPDATE 2-Immucor gets FDA notice to revoke reagent license

Fri Jun 26, 2009 1:29pm EDT

* Has 10 days to respond to FDA's action

* FDA's notice based on Jan 2009 inspection

* Shares down as much as 30 pct (Adds analyst's comments, updates share movement)

By Anand Basu

BANGALORE, June 26 (Reuters) - Blood-testing products maker Immucor Inc BLUD.O said U.S. health regulators issued a notice of intent to revoke the biologics license for some of the company's blood reagents based on a January 2009 inspection, sending its shares down as much as 30 percent to their four-year low.

The company said the notice was related to two of its blood products -- Reagent Red Blood Cells and Anti-E Blood (Monoclonal) Grouping Reagent product -- that are used to detect antigen and antibody reactions. The two products are mostly used by blood banks.

However, the FDA has not ordered the recall of any of the products, Immucor said in a statement.

"I don't believe that the U.S. Food and Drug Administration (FDA) intends to put this company out of business," Susquehanna Financial Group analyst David Turkaly said.

The FDA will comeback for another inspection after submission of company's response, he added.

The company said it has 10 working days to respond to the FDA's administrative action and 30 days to submit a remediation plan.

The FDA could either end the matter there or put the company in consent decree, where the FDA will be involved in the manufacturing process, before taking any decision on revoking the license, Turkaly said.

Earlier in May 2008, Immucor received a similar warning letter from the FDA related to its internal quality system, which the company was able to resolve successfully.

"I think that there is a chance that after the inspection the FDA might say OK," he said. "The company is spending a lot of money and they have been sending the FDA monthly updates," he added.

Immucor spent more than $2 million on its quality process improvement project in 2009 to improve its quality systems and expects to spend between $4 million and $4.5 million on the project in 2010.

"We have been working diligently to improve our quality systems and processes, including the deficiencies identified by the FDA, with our quality process improvement project," Chief Executive Gioacchino Chirico said in a statement.

Immucor will use the remediation work that is already underway and documented in detail to the FDA, to facilitate its response.

Shares of the company were down $2.34 at $13.75 in afternoon trade Friday on Nasdaq. Earlier they touched a four-year low of $11.24.

For the alerts double-click [ID:nWNAB2530] . (Editing by Jarshad Kakkrakandy)

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