Immucor To Respond To FDA Notice

FDA has issued a notice of intent to Immucor to revoke its biologics license, with respect to its Reagent Red Blood Cells and Anti-E Blood Grouping Reagent product.

As per FDA’ letter, the company has 10 working days to respond to FDA’ administrative action and 30 days to submit a remediation plan. The company will use the extensive remediation work already underway and documented in detail, to FDA to facilitate its response.

Dr De Chirico, President and CEO, Immucor, said: We take our regulatory responsibilities very seriously. 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. We are committed to completing this Project as quickly as possible.

During its fiscal third quarter of 2009, the company formalized efforts to improve its quality systems through the ‘Quality Process Improvement Project’.

Dr. De Chirico added: We have kept the FDA informed of the Project’s objectives and progress by providing written updates to them on a monthly basis that detail our plans for corrective actions as well as the implementation of the correction action plans to prevent recurrence. The FDA has acknowledged that they are aware of our efforts to correct their identified deficiencies, but the letter indicates the FDA’s action is based on their January 2009 inspection. The FDA has not performed an inspection since January 2009.