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Immucor loses biologics licenses

This article was originally published in The Gray Sheet

Executive Summary

FDA issues notice of intent to revoke blood-transfusion reagent and instrument maker Immucor's biologics license for its Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent products, based on a January 2009 inspection, the firm announces June 26. However, the agency has not ordered a recall of the affected products. Immucor previously received an FDA warning letter May 2, 2008, citing "significant objectionable conditions" related to the firm's serological reagent manufacturing process. Immucor says it is "working diligently" to improve its quality system through a "Quality Process Improvement Project" launched in fiscal 2009. The firm spent more than $2 million on the project in FY 2009 and plans to spend $4 million-$4.5 million in FY 2010. Immucor has 10 days to respond to FDA's notice and 30 days to submit a remediation plan
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