Immucor Inc. said Federal authorities have issued a notice of intent to revoke the company's biologics license after an inspection in January 2009 and discovering "deficiencies" in the company's manufacturing.

The Norcross-based company, makes and supplies blood-reagent systems to the blood transfusion industry, and said the notice had sent the company shares plummeting by as much as 30 % to a four year low.

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

In a statement Immucor said that the FDA had however not ordered any recall of the products. David Turkaly, Susquehanna Financial Group analyst said, "I don't believe that the U. S. Food and Drug Administration (FDA) intends to put this company out of business." He added that the FDA will comeback for another inspection after submission of company's response.

The FDA could go two ways the first being ending the matter there or it could 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.

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

In 2007, the company paid a $30,000 settlement to the Securities and Exchange Commission related to charges of improper payments Immucor's Italian subsidiary allegedly made to an Italian physician. That same year, the Federal Trade Commission asked the company for certain documents and information about three acquisitions the company made from 1996 to 1999 regarding product pricing activities.

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. In late April, the company said it got a subpoena from the U. S. Department of Justice's Antitrust Division asking for documents for the period beginning Sept. 1, 2000 through the present, pertaining to an investigation of possible violations of the federal criminal antitrust laws in the blood reagents industry.

Immucor said it spent more than $2 million during fiscal 2009 on improving quality systems and it expects to spend up to $4.5 million on the project in 2010. In a statement Chief Executive Gioacchino Chirico said, "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."

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