We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of active pharmaceutical ingredient with conforming batches. Read More
The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More
OTC drugmaker Advance Pharmaceutical has landed in hot water with the FDA again, getting another Form 483 for various quality issues including a lack of data integrity practices. Read More
The FDA has warned an Indian active pharmaceutical ingredient manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records. Read More
The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More
The FDA has warned GlaxoSmithKline subsidiary SmithKline Beecham over its failure to adequately address contamination of drug ingredients manufactured at its Currabinny, Carrigaline, Cork, Ireland, plant. Read More
The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
The FDA has warned GlaxoSmithKline subsidiary SmithKline Beecham over its failure to adequately address contamination of drug ingredients manufactured at its Currabinny, Carrigaline, Cork, Ireland, plant. Read More
The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of API with conforming batches. Read More