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IBSA Farmaceutici did not open a corrective action, as required, for a trend in adverse events involving pain and/or swelling in the knee following injection of Sinovial or other sodium hyaluronate devices, according to a Form 483. Read More
Health Line International, a Chinese devicemaker, received an FDA Form 483 for delaying effectiveness checks on CAPAs and other quality issues. Read More
Over the next four years, the U.S. Food and Drug Administration plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The U.S. Food and Drug Administration and Customs and Border Protection are accepting applications for an 18-month pilot of a “trusted trader” program. The initiative aims to reduce inspections and oversight of products imported from manufacturers that establish tough internal import control programs of their own. Read More
Health Canada has published its 2014 list recognized medical device standards, adding 15 new standards and 10 new editions of currently recognized standards Read More
The China Food and Drug Administration published 120 new medtech standards covering everything from metal spine implant system components to blood analyzer reagents, total knee and hip implants and endoscopic instruments. Read More