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Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
The FDA delivered its fifth warning letter to a compounding pharmacy in roughly two weeks, admonishing a Texas compounder for poor aseptic processing of sterile drugs. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More
German manufacturer Fresenius Kabi’s U.S. subsidiary is recalling nearly 3 million vials of an injectable anti-seizure medication due to glass flakes in sample vials. Read More
Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates. Read More
The FDA expects to start collecting manufacturing quality metrics data from drugmakers sometime in 2015, a move agency officials say will cost manufacturers little but pay off in the potential for fewer inspections. Read More
The FDA released its fourth warning letter in two days against a compounding pharmacy, this time chiding a large compounder for a mixture of quality violations at its four facilities. Read More
The FDA cited a trio of compounders for a wide swath of quality violations, igniting renewed criticism that the agency is “unjustified” in using a new law to enforce old violations. Read More
After initially rejecting FDA’s authority, a Texas compounding pharmacy acceded to the agency’s request to cease production and recall all of its sterile products due to quality concerns. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. Read More