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CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. Read More
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., Canada, Australia and Brazil were supposed to begin shared audits in June under the International Medical Device Regulators Forum’s medical device single audit program. Read More
As of April, EU member states and the European Commission had conducted five mandatory joint assessments of notified bodies, with one resulting in a negative decision, according to a working document prepared by Commission staff and presented to the Council of the European Union. Read More
Ventlab has received an FDA warning letter for its handling of complaints and a corrective and preventive action related to nonconforming manual resuscitation bag components. Read More
The Utopia Group, a specification developer for an umbilical cord clamp and cutter, received an FDA warning letter for making product changes without following regulations and for lacking a host of procedures. Read More
Devicemakers should never be concerned that an FDA inspector will cite them for opening “too many” corrective and preventative actions, a CDRH official says. Read More
Over the next four years, the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The U.S., Canada, Australia and Brazil were supposed to begin shared audits this month under the International Medical Device Regulators Forum’s medical device single audit program. Read More
Coronary devicemaker HeartWare International has received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility. Read More