FDA sends Immucor warning letter

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FDA sends Immucor warning letter

May 14th, 2008 joshua

The Food and Drug Administration sent a warning letter, dated May 2, to Immucor Inc., regarding problems with the manufacture of its blood testing products.

The FDA says the company “failed to establish and maintain procedures to control product that does not conform to specified requirements.”

Reuters reports the FDA is citing the company for sending out lots of the product before proper investigations were completed.

Immucor said it is working to remedy the problems noted in the FDA letter and maintained a positive tone, saying regulators did not recall any products.

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