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The FDA cited two device manufacturers and an importer after inspections identified issues with procedures, including product acceptance, complaint handling and medical device reporting. Read More
The investigator observed that the firm’s device master record for fixation screws did not define certain specifications, including packaging, labeling, acceptance criteria and quality assurance. Read More
The FDA was not impressed with Korean devicemaker Dexcowin’s responses to a Form 483 it received following an August 2017 inspection of its facility in Seoul. The agency received two responses from the manufacturer of portable dental X-rays, but then issued a 13-item warning letter. Read More
FDA investigators uncovered numerous quality system deficiencies during a December 2017 inspection of Laser Dental Innovations’ San Jose, California plant. Read More
The inspector reviewed 123 complaints related to reports of infections and/or deaths for which the company had not opened corrective or preventive action files. Read More