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FDAnews Drug Daily Bulletin
Aug. 28, 2012 | Vol. 9 No. 169
India’s Claris, Spanish API Maker Get FDA Closeout Letters
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.
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