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The FDA slapped Xellia Pharmaceuticals with a Form 483 after finding quality and sterility shortcomings during a May inspection of its Copenhagen facility. Read More
The FDA flagged UBI Pharma for a slew of violations at its Hsinchu County, Taiwan, facility including inadequate environmental monitoring and sterility practices. Read More
The FDA hit Montreal-based drugmaker Lernapharm (Loris) with a warning letter over serious sterility violations and air filtration problems that were not resolved after a December 2017 inspection. Read More
The FDA hit Guadalajara, Jalisco-based drug manufacturer Jabones y Productos Especializados (Soaps and Specialized Products) with a Form 483 for multiple violations, including serious quality deficiencies, observed during a March 20-23 inspection. Read More
The FDA hit Indian injectable drugmaker Auronext Pharma over violations found during a February inspection of the company’s Bhiwadi, Rajasthan facility. Read More