Immucor Says FDA Could Revoke License

NORCROSS, Ga. (AP) -- Immucor Inc., which makes products used in blood transfusions, said Friday the Food and Drug Administration intends to revoke the company's biologics manufacturing license, citing a January inspection.

The notice is based on a January FDA inspection, though the company said it has been working "diligently" to improve its manufacturing processes. No products are being recalled as a result of the notice.

In May 2008, the FDA warned the company about violations at its Norcross plant that included handling procedures. In some cases, the company had released batches of blood tests that had bacterial contamination before completing an investigation.

Specifically, the notice refers to the company's reagent red blood cells and Anti-E blood grouping reagent product.

"We take our regulatory responsibilities very seriously," said President and CEO Gioacchino De Chirico in a statement. "We have been working diligently to improve our quality systems and processes, including the deficiencies identified by the FDA, with our quality process improvement."

The company spent more than $2 million in fiscal 2009 on improvements. In fiscal 2010, the company expects to spend between $4 million and $4.5 million on improvement projects.

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

Shares of Immucor fell $2.76, or 17.2 percent, to $13.33 in morning trading. The stock reached a five-year low of $11.24 earlier in the trading session.

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