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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
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies, and all for data integrity issues. Read More
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
The FDA’s new team-based inspection program is starting to take shape with a steering committee led by high-ranking FDA officials and three subgroups. Read More
The FDA’s new proposed team-based inspection program completed initial inspections in its ongoing pilot and was deemed a huge success that helped investigators plan better inspections. Read More