Sandoz and Novartis announced that the U.S. Food and Drug Administration (FDA) issued a Warning Letter concerning the company’s Unterach, Austria site.
The warning letter observations by the FDA follow an agency inspection at the site in October 2012, and are related to visual inspection of products manufactured at the site. The site became part of Sandoz and Novartis through the acquisition of EBEWE Pharma in 2009.
“We take seriously the warning letter observations cited by the FDA and will work closely and expeditiously to address these concerns to the agency’s full satisfaction,” said Ameet Mallik, Sandoz’ Head of Biopharmaceuticals & Oncology Injectables. “Sandoz has made strong progress in strengthening operations in Unterach through significant investments in both resources and state-of-the-art technologies. We remain deeply committed to fully addressing all outstanding issues and meeting all quality standards.”
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