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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
In another twist in the worldwide recall of the contaminated blood pressure medication, valsartan, the FDA released two Form 483 reports issued to the API’s manufacturer in China after inspections in 2016 and 2017. Read More
The FDA hit German drug and API manufacturer Boehringer Ingelheim with a Form 483 for recordkeeping shortcomings at its Ingelheim am Rhein facility. Read More