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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
The FDA has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More
A flu vaccine manufacturing site that was recently transferred from Novartis to CSL Limited received an FDA Form 483 for problems with cleaning equipment, stability studies, batch certification and other issues. Read More
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
Last month, the FDA zapped seven more compounders in Tennessee, California, Florida, Arkansas, Montana and Washington over sterility issues. The FDA handed out three warning letters, three Form 483s and one facility issued a recall following an inspection. Read More
The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant. The drugmaker has been plagued in recent months over recalls of sterile IV solutions. Read More