After learning that a transport trailer carrying 9,000 vials of high-value injectable medications was stolen while in transit in Tennessee, Johnson & Johnson (J&J) recalled several lots of the drugs associated with the shipment.Read More
Baxter is refuting charges made last month by China’s State Food and Drug Administration (SFDA) that the company did not cooperate with Chinese inspectors during an audit of its heparin finished dose plant in New Jersey.Read More
Center for Drug Evaluation and Research (CDER) Director Janet Woodcock plans to refocus the center’s efforts on the FDA’s GMPs for the 21st Century initiative now that she is permanent director of the drugs center.Read More
While the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) supports the European Commission’s (EC) proposal to combat drug counterfeiting, it says certain requirements conflict with UK regulations.Read More
As Stryker’s hip implant franchise took a $15 million to $20 million hit last quarter due to a recall and temporary production stoppage of its implantable hip cups, the company is spending millions of dollars instituting a corporatewide quality control program to resolve two FDA warning letters.Read More
Quality issues at Zimmer Holdings’ surgical support accessories plant in Dover, Ohio, has forced the company to halt production at the site, costing an estimated $70 million to $80 million in lost revenue for 2008.Read More
Medtronic may continue to ship some LifePak external defibrillators for emergency use under a consent decree it agreed to with the FDA for its troubled Physio-Control division, which manufactures defibrillators in Redmond, Wash.Read More
Actavis Totowa, a U.S. manufacturing division of Icelandic drugmaker Actavis, has recalled all lots of heart failure treatment Digitek as a precautionary measure.Read More
While settling patent litigation last month over the blockbuster acid reflux disease treatment Nexium, AstraZeneca and Ranbaxy entered into manufacturing agreements for several drugs.Read More
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!
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