FDA May Refuse Drug Imports From Austrian Novartis Facility
The Food and Drug Administration may refuse entry to drug products manufactured at Novartis’ Ebewe Pharma facility in Austria, alleging that a drug produced at the facility is unapproved for U.S. distribution. According to the FDA warning letter, Novartis distributed…
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the drug without the required FDA marketing application. The agency also alleged violations of current good manufacturing practice requirements at the facility.