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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
The FDA handed Noven Pharmaceuticals a 13-item Form 483 for lapses in batch reviews and testing, stability and process controls and complaint handling. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif., manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
The FDA Wednesday placed another Indian active pharmaceutical ingredient maker on its import alert list, adding one of Megafine Pharma sites to 46 other India-based finished drug and API sites whose products are banned from entering the U.S. Read More
The FDA handed Galena Biopharma a 10-item Form 483 for lapses in adverse drug event reporting — some of them repeat observations — following a reinspection of its Portland, Ore., facility. 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