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Cook Medical initiated a global recall of its Beacon Tip catheters, following reports of degrading polymer in the catheter tips, which may lead to fracture or separation. Read More
Dialysis Medical Solutions received a Form 483 for inadequate documentation for corrective and preventive action and other quality failures for its dialysis products. Read More
Newly released government data shows the FDA has been conducting more quality systems inspections at foreign devicemakers to keep up with rapidly growing inventory at those manufacturers. Read More
Innovative Sterilization Technologies has received an FDA warning letter for failing to establish and maintain procedures when dealing with contract manufacturers. Read More
The third time is not always the charm, as radiology clinic MRI Imaging Specialist learned the hard way following three failed FDA inspections in nearly two years, a recent FDA warning letter shows. Read More
Dealing with tense inspections can be challenging, but learning what to do in real-world scenarios can help firms prepare. Steve Niedelman, lead quality systems and compliance consultant at King & Spalding and former FDA deputy associate commissioner for regulatory operations, and Elaine Messa, president of the Medical Device Practice at NSF Health Sciences and former director of the Los Angeles District at the FDA, provide advice on the topic during the FDAnews’ Medical Device Quality Congress on March 16. Read More
Terumo Medical has earned a warning letter from the FDA due to procedural failures for controlling product conformity, as well as validating and verifying device design. Read More
Devicemakers should start thinking about restructuring their quality system away from the quality system inspection technique toward the medical device single audit program. Read More
Chester, N.Y.-based Repro-Med, a manufacturer of infusion pumps and intravascular administration sets, has earned an FDA warning letter for failures involving quality systems and medical device reporting, as well as other violations. Read More
An FDA warning letter takes SureTek Medical to task for its procedures related to assessing contamination for reprocessed single-use devices. Read More