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The FDA is questioning Mylan’s ability to achieve overall GMP compliance at three injectables manufacturing plants in India after finding serious deviations that should have been corrected after the drugmaker acquired Agila in December 2013. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More
Contract manufacturer Pernix Manufacturing received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
Pfizer’s Dalian, Liaoning, China, facility received a six-observation Form 483 for retesting failed samples, poor record controls and using an open pit for a urinal. Read More
Genzyme received a 16-observation Form 483 from the FDA for not conducting risk assessments and other quality lapses at a facility where bulk drug substances are made. Read More
The FDA cited Novartis’ Vaccines and Diagnostics facility located in Liverpool, UK, for numerous lapses in its equipment cleaning and validation processes and inadequate investigations and CAPAs in a Form 483 issued June 11. Read More
The FDA has cited data integrity as one of the most important GMP issues because it lies at the crux of all GMP systems. John Avellanet, managing director and principal at Cerulean Associates, sat down with FDAnews to talk about how companies should be handling their data.Read More
Members of the House Energy & Commerce Committee requested the FDA to provide information on whether NIH included any statements about quality control, sterility or cGMP compliance in INDs it filed with the agency. Read More
Companies should pay close attention to quality system lapses at other firms and learn from them, warned Tom Cosgrove, director of the Office of Manufacturing Quality within CDER’s Office of Pharmaceutical Quality. Read More
Lapses in quality management systems and adverse event reporting topped the list of major deviations found during EU postmarking inspections last year, with 18 sites cited for QMS issues and 13 for AE reporting. Read More
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. Read More
Beleaguered Indian companies continue to stumble when it comes to quality issues, with generics maker Wockhardt conducting yet another recall, and active pharmaceutical ingredients makers Mahendra Chemicals and Nosch Labs racking up GMP deficiencies. Read More