Jan. 27, 2012 | Vol. 4 No. 4
Ranbaxy’s “unprecedented” consent decree is a nightmare on a global scale for the company, but could have been avoided by being properly prepared.
The world can be a scary place for devicemakers trying to keep up with ever-changing regulatory requirements in multiple countries.
Since 2009, warning letter citations make clear that it’s no longer enough for devicemakers to look back at data and then react to quality problems. You are now expected to trend your quality data.
Supply chain disasters happen only occasionally, but badly executed supplier agreements cause headaches every day — among them finger-pointing, misunderstandings, even lawsuits.
Genzyme can begin manufacturing Fabry disease drug Fabrazyme at its Framingham, Mass., plant after winning FDA approval for the facility.
Durable medical equipment giant Invacare is negotiating a consent decree with the FDA that would temporarily shut some Ohio operations, the company revealed last month.
Nephron Pharmaceuticals may have inadvertently distributed batches of asthma medicine befouled by Bacillus bacteria, an FDA Form 483 states.
The FDA slapped Johnson & Johnson’s DePuy Orthopaedics with a Dec. 8 warning letter for distributing devices without premarket approval.
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