FDAnews Drug Daily Bulletin

India’s Claris, Spanish API Maker Get FDA Closeout Letters

Aug. 28, 2012
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Significant deviations from good manufacturing practices at India’s Claris Lifesciences and Spain’s Moehs Iberica S.L. appear to be resolved as both companies received closeout letters from the FDA. Claris received a warning letter in late 2010 citing investigation failures after metronidazole injection IV bags were found to be contaminated with a “swirling mass” identified as a fungus.
Washington Drug Letter