May 17, 2013 | Vol. 5 No. 20
The method Novartis uses to clear batches at its Suffern, N.Y., facility was deemed inadequate by FDA investigators, resulting in a Form 483.
Companies drafting a social media policy in anticipation of upcoming FDA guidance should try to follow the same general guidelines used for traditional marketing materials, experts advise.
The FDA has warned GRI Medical & Electronic Technology for corrective and preventive action (CAPA) shortfalls and its handling of nonconforming product.
Just two months after its first commercial sale, Biotest Pharmaceuticals has voluntarily recalled one lot of its immunodeficiency drug Bivigam due to visible particles.
Genentech is working to figure out why some vials of blood clot drug Cathflo Activase contain rubber stopper particulates.
Generic drugmaker Ranbaxy said it has agreed to a $500 million settlement with the Department of Justice following allegations of poor data integrity and manufacturing practices at three of its Indian facilities and a facility in Upstate New York.
CDER Director Janet Woodcock, appearing before a Senate panel May 9, reiterated the FDA’s call for enhanced authority to seize compounding pharmacy records.
The FDA has warned Biocompatibles, a maker of radioactive brachytherapy needle sets, for process validation failures and for not initiating corrective actions after complaints of injection errors.
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