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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
Cook Medical is recalling 360 specific lots of single lumen central venous catheters and pressure monitoring sets and trays due to catheter tip fracture and/or separation. 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
Wayne, Pa.-based Teleflex is recalling 47,140 units of its Arrow International intra-aortic balloon pump catheters and percutaneous insertion kits following reports of serious adverse events. 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
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