Monday, automated systems and reagent provider Immucor, Inc. (BLUD), announced the submission of its formal 10 day response to the Food and Drug Administration's administrative action announced on June 26, 2009.
Immucor said the response reaffirms its commitment to implement corrective actions that address both the FDA's noted deficiencies and establish a world-class quality system. The company will also provide its detailed action plan in its 30 - day response to the FDA by August 11, 2009.
Gioacchino Chirico, Immucor's President and Chief Executive Officer said, "We take our regulatory responsibilities very seriously. We began our Quality Process Improvement Project in early 2009 to bring our quality system up to world-class standards. We remain committed to completing this Project as quickly as possible."
Earlier, Immucor revealed a notice of intent to revoke its biologics license from the FDA related to its Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent products. The action was based on a January 2009 inspection and the notice has a revised effective date of June 30, 2009.
Immucor further stated that however, the FDA has not ordered the recall or banned the sale of any of the its products. The company announced the creation of a Product Surveillance and Improvement Department to support the quality system in the production line. Focusing on product quality, the new department will provide a single internal focal point to monitor quality issues, whether identified through internal or external sources, and initiate the appropriate corrective actions immediately.
BLUD closed Monday's regular trading at $14.4, up $0.59 or 4.25%, on a volume of 1.34 million shares on the Nasdaq.
For comments and feedback: editorial@rttnews.com