Tag:
Warning Letter
Latest Headlines
Latest Headlines
Integra collagen plant fights mold
Integra LifeSciences, which manufacturers medical devices used in surgery, has been fighting a mold problem at its collagen manufacturing facility in Plainsboro, NJ, for more than two years, the FDA...
Warnings analysis spotlights analytics weakness
Analytics issues appear in the majority of FDA warning letter citations for manufacturing, including unvalidated methods and inadequate procedures for responding to out-of-spec test results. The...
Genzyme plant approval marks GMP comeback
The Genzyme unit of Sanofi ( $SNY ) announced today that it has won FDA approval for its new Framingham, MA, facility, the new production home of Fabry disease drug Fabrazyme. The plant won European ...
Novartis recall hints at regulatory snowball
Uh-oh. Novartis ( $NVS ) is recalling some OTC drugs made at a Nebraska plant that was recently shut down for maintenance and upgrades. The voluntary recall is one thing. But the recall's timing, so
FDA cites Akzo for contamination, leaky equipment
Recurring oil leaks in manufacturing equipment, likely the cause of black particle contamination in 13 batches of API, led to Warning Letter 320-12-004 to Akzo Nobel Chemicals in Mexico. The letter
Troubles top 2011 topics; time for holiday break
We're taking a break between holidays, with our next issue hurtling through cyberspace to your inbox on Tuesday, Jan. 3. That'll be 2012. Our most popular topics this year, judging by the number of
Actavis, Mylan continue defense in Digitek API suits
The family of a heart patient who died while taking atrial-fibrillation drug Digitek is appealing a West Virginia judge's ruling exonerating manufacturer Actavis and distributor Mylan ( $MYL ). Quality
Analyst: Hospira manufacturing woes possibly systemic
Production problems continue to be a drag on Hospira ( $HSP ), despite last week's announcement of a planned $375 million investment in operations upgrades. The drugmaker's current troubles provide
Mylan warned by FDA on testing failures
Mylan ( $MYL ) CEO Robert Coury ( photo ) was sent an FDA warning letter in mid-October as a result of a January-February 2011 inspection of a Puerto Rico plant. The letter, which was just posted to the
Genentech, INIS demonstrate art of FDA response
Genentech and International Isotopes ( $INIS ) appear to be setting casebook examples of how to respond to the FDA over GMP concerns. Both companies filed responses to the agency within the allotted
