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www.fdanews.com/articles/130854-ohm-gets-483-after-inspectors-find-lsquo-destroyed-rsquo-tablets

Ohm Gets 483 After Inspectors Find ‘Destroyed’ Tablets

October 7, 2010
FDA inspectors found fenofibrate tablets in Ohm Laboratories’ warehouse even though documents indicated the tablets were sent out for destruction. The employees involved in the documentation error were never retrained or disciplined, and Ohm had not taken corrective actions at the time of the inspection, according to a July 14 Form 483. Deviations from Ohm’s stability program also could not be explained. Ohm has responded to the FDA, company spokesman Chuck Caprariello said.
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