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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
Class II device manufacturer Arrowhead Dental was cited for failure to develop design control and medical device reporting procedures among other quality failures in a Form 483 issued following a December 2017 inspection of the firm’s Sandy, Utah facility. Read More