Based on a January 2009 inspection, U. S. health regulators have issued a notice of intent to Immucor Inc., a blood-testing product manufacturer, specifying their intention to revoke the company's biologics licence for some its blood reagents, sending its shares down 30% to their four-year low.

Notice has been issued to the company for Reagent Red Blood Cells and Anti-E Blood (Monoclonal) Grouping Reagent product, two products mostly used by blood banks, and that are used for detecting antigen and anti-body reactions.

FDA has not ordered recall of any of its products and will carry out another inspection after Immucor, who has 10-working days to respond to FDA's administrative action and 30-days to come up with a remediation plan, submits its response.

The matter will either end there, or else FDA could put the company in consent decree, which means the involvement of FDA in the manufacturing process, before any decision is taken on revoking the license.

A similar warning letter was issued to Immucor, earlier in May 2008, relating to its internal quality system, which was resolved successfully.

In 2009, $2-million has been spent by Immucor on its quality process improvement project, while it expects to spend between $4-million and $4.5-million on improving the project's quality systems in 2010.

Remediation work already underway, will be documented in detail for facilitating Immucor's response to the FDA.

Shares of the company in afternoon trading on the Nasdaq were down $2.34 at $13.75 Friday, after touching a four-year low of $11.24, earlier.