Caraco signs consent decree
This article was originally published in The Gold Sheet
Executive Summary
Caraco Pharmaceutical Laboratories Ltd., can resume drug manufacturing operations at its Detroit facilities once it has satisfied the terms of a Sept. 29 FDA consent decree. The company has retained independent cGMP experts who, along with FDA, must certify in writing that it has complied with the consent decree's terms before manufacturing can resume. The plants were shut down after making digoxin tablets of varying thickness and having difficulty clearing lines of stray tablets (1"The Gold Sheet," August 2009)