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Failure to establish a design history file or to put procedures in place to control device history records, in addition to failure to conduct quality reviews, landed devicemaker LSVT Global a 10-item Form 483 following a July 16 to July 17 inspection of is plant in Tucson, Arizona. Read More
Procedures for submitting medical device reports to the FDA, as well as inadequate CAPA procedures were among the numerous quality system failures uncovered during a Jan. 29 to Feb. 1 inspection of Beijing Polycon Medical Engineering’s plant in Beijing. Read More
Sites running clinical trials for devices should document all adverse events and investigators’ responses even if they don’t ultimately report the events to regulators or Institutional Review Boards, a contract research organization executive told the MAGI clinical research conference in San Diego last week. Read More
Cair LGL, a manufacturer of medical devices and equipment for hospitals, failed to properly submit MDRs, adequately maintain complaint files or evaluate complaints, the FDA said following a February inspection of its facility in Lissieu, France. Read More
In a warning letter to Becton Dickinson Medical System, the FDA said the devicemaker must further document its corrections to problems with environmental conditions and safeguards against contamination. Read More
The complaint said the device’s bullet tip fell off during a surgical procedure and had to be removed from the patient through medical intervention. Read More