The Food and Drug Administration has sent a letter to Immucor, a blood-transfusion products company in Norcross, Ga., saying that it intends to revoke the suppliers license for manufacturing certain products as a result of a failed January 2009 inspection.
In a news release, Immucor officials said they are working to address the problems identified by the FDA inspection, and that it has spent $2 million so far this year improving its manufacturing process. The company anticipates spending up to $4.5 million in 2010 to complete improvements.
Immucor has not disclosed the nature of the manufacturing deficiencies but said they are related to production of reagent red blood cells and anti-E blood group reagent, which are used in antibody screening. The company has 10 days to respond the FDAs letter and 30 days to submit a remediation plan.