FDA Puts Immucor On Notice For Safety Violations

Law360, New York (May 14, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has warned Immucor Inc. of severe regulatory action after numerous product safety violations were found at a facility of the medical equipment manufacturer.

FDA Enforcement Director David K. Elder sent Immucor a formal warning letter on May 2.

The document, which the FDA made public Tuesday, outlines several alleged violations of the Food, Drug & Cosmetic Act and gives Immucor 15 business days either to resolve them or to explain in writing why it needs more time.

“Failure to promptly...
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