FDA warns novartis of violations at three plants

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http://www.mdlinx.com/pharma-news/newsl-article.cfm/3877927/ZZ5C5DCF82AC164CBEAC1A66F4ECE91FE3/?news_id=1105 & newsdt=122311FDA warns novartis of violations at three plants Full Text Pharmaceutical Technology, 12/23/2011In a Warning Letter, FDA cited significant violations of CGMP regulations, including several repeat observations, at three Novartis facilities. The violations included failure to prevent microbiological contamination of sterile drug products, failure to investigate out–of–specification batches, failure to clean and maintain equipment, and failure to ensure drugs’ identity, strength, quality, and purity.