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Novartis’ generics unit Sandoz received a warning letter from the FDA citing cGMP deficiencies for finished drugs at the company’s plants in Kalwe and Turbhe, India. Read More
The FDA handed SSM Health Care a warning letter for GMP deficiencies in compounding sterile drug products as well as failure to follow 503B conditions for outsourcing facilities at its Fenton, Mo., facility. Read More
The FDA’s program alignment will see district offices and laboratories focus only on one category of products, primarily designated by geographic location and the types of industries that surround those locations, FDA Acting Commissioner Stephen Ostroff said. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
The FDA cited Novartis’ Vaccines and Diagnostics facility in Liverpool, UK, for lapses in its equipment cleaning and validation processes and inadequate investigations and CAPAs in a Form 483 issued June 11. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
The FDA has quietly removed a September 2014 warning letter issued to Pacira Pharmaceuticals for touting unapproved uses of its analgesic Exparel. Read More