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The FDA said its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More
Two Alabama compounders face federal charges for selling tainted drugs that contributed to the deaths of nine people, according to federal prosecutors. Read More
The Office of Manufacturing Quality’s 2015 annual report of warning letters blasted the drugmakers for disregarding previous inspection findings. Read More
The FDA repeatedly blasted overseas drugmakers last year for disregarding previous inspection findings and not living up to promises to carry out proper GMP practices for active pharmaceutical ingredients. Read More
The FDA has issued warning letters to two U.S. dietary supplement makers and a Hong Kong drugmaker — already under import alert in the U.S. — for significant cGMP violations over adulterated products and data integrity issues. Read More
Effective standard operating procedures are central to any life sciences company, but the FDA’s pharmaceutical regulations don’t mention SOPs specifically. Instead, regulations refer to “procedures” related to quality control and require them to be maintained in writing. Read More
Indian analysts attribute ongoing quality control issues with pharmaceutical exports to a dearth of pharmaceutical inspectors and a lack of uniform standards in the country. Read More
Drugmakers that have not started complying with worldwide track and trace regulations are behind the curve, as most countries only allow for two to three years for implementation, a supply chain expert cautions. Read More
The FDA continues to turn up the heat on compounding pharmacies, issuing two warning letters to compounders in Kentucky and California for serious GMP deficiencies related to sterility. Read More
A federal judge has signed off on a Justice Department-backed consent decree for a permanent injunction against Texas compounder Downing Labs. Read More