Immucor Replies to FDA Notice

Immucor (BLUD - Analyst Report) recently replied to the U.S. Food and Drug Administration’s (FDA) notice that intended to revoke the company's biologics manufacturing licensefor two of its products – Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent. The FDA took the administrative action last month based on an inspection that it held in early January this year.

However, the FDA did not recall any product from the company. Immucor had to submit a preliminary response to the FDA within 10 working days.
 
Immucor has also set up a new Product Surveillance and Improvement Department to support the ongoing Quality Process Improvement Project of the company. The new department will act as a single internal focal point to check all quality issues – raised by internal as well as external sources. It will also take suitable remedial measures as and when required. Immucor is required to present a detailed remediation plan and timelines to the FDA latest by August 11, 2009.
 
Immucor had already initiated the Quality Process Improvement Project during the third quarter of fiscal year 2009 to improve overall quality within the organization – including the deficiencies identified by the FDA. The company has already spent over $2 million during on the project and expects to spend another $4.0-4.5 million in fiscal year 2010. Immucor expects to finish the project during the third quarter of FY 2010.