Johnson & Johnson (J&J) subsidiary McNeil Consumer Healthcare is recalling three Tylenol liquid products, 12 Mylanta liquid products and one AlternaGEL liquid product due to a labeling issue discovered during an ongoing review of its quality systems.
Recent FDA warnings that it will hold pharma executives accountable for companies’ violations signify “somewhat of a change in philosophy,” for the agency as it works to identify and publicize industry-wide quality issues sooner, an FDA official says.
Johnson & Johnson (J&J) subsidiary Janssen-Cilag and Takeda subsidiary Millennium Pharmaceuticals are recalling 395,000 vials of their cancer drug Velcade after five reports of small, white polyester particles in the product.
Drugmakers and distributors should not store drug products, components or packaging materials near wood or wood-derived storage materials unless they know the material has not been treated with a preservative known to emit a moldy or musty odor that can pervade medicine bottles, the FDA says.
Contract manufacturer Nexgen Pharma has received an FDA warning letter citing several significant cGMP violations for finished pharmaceuticals, including issues with its cleaning and testing processes.
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today.Read More
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!