FDA Chides Mylan Over Puerto Rico Plant Violations

Law360, New York (November 22, 2011, 5:00 PM EST) -- The U.S. Food and Drug Administration found several violations of manufacturing regulations at a Mylan Inc. facility in Puerto Rico, including a failure to test drugs for uniformity, according to a letter published Tuesday.

The FDA sent the generic-drug company a warning letter Oct. 13 regarding what it called significant violations of current good manufacturing practice regulations for finished pharmaceuticals at its Caguas, Puerto Rico, plant. The agency said it inspected the facility from Jan. 24 to Feb. 24.

“We intend to work closely with FDA...
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