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Inadequate investigations and corrective and preventive actions have been one of the top reasons for 483 observations since 1997, says James Vesper, president of LearningPlus. A 30-year veteran in the pharma business, Vesper explains how to develop a successful CAPA program to uncover root causes of quality failures. Read More
As global outsourcing has made managing supply chains more difficult, a group of 12 devicemakers has taken matters into its own hands to develop a supplier accreditation program to ensure quality and to be a step ahead of FDA inspectors. Read More
TÜV Rheinland has scored another victory in a French court in a case involving faulty breast implants. However, its fate in another case is up in the air as it awaits a decision from the European Court of Justice. Read More
The FDA is reminding manufacturers of surgical gowns that they need to submit a 510(k) application to commercially distribute their products. Read More
Following more than 5,000 complaints including reports of patient injuries and four deaths, the FDA is taking a second look at the safety and effectiveness of Bayer’s Essure birth control implant. Read More
As global outsourcing has made managing supply chains more difficult, a group of 12 devicemakers has taken matters into its own hands to develop a supplier accreditation program to ensure quality and to be a step ahead of FDA inspectors. Read More
BD’s CareFusion subsidiary issued an update on its recall of the Avea ventilator to provide clarification on certain units of the product. The device is intended for continuous breathing support in infants through adults. Read More
The China Food and Drug Administration has issued 90 industry standards — 14 mandatory and 76 recommended — covering implants for surgery, medical electrical equipment, in vitro diagnostic reagents and dentistry. Read More
A contact lens manufacturer that failed to respond to a Form 483 in February following an FDA inspection now must respond to a warning letter. Read More