FDA Warning Letters Focus on Recalls, Clearance, Reporting and Quality Issues

Deficiencies in manufacturing quality, failure to report device recalls, lack of marketing clearance and the absence of any written medical device reporting procedures all were issues featured in device company warning letters the Food and Drug Administration posted online in December.

Miriam R. Burbach, director of the FDA’s Seattle District Office, told Sagemax Bioceramics Inc., of Federal Way, Wash., that its NexxZr T High Translucency Dental Zirconia and NexxZr S Highest Strength Dental Zirconia devices were adulterated because of quality violations discovered during an August 2014 inspection.

The letter, dated Dec. 9, 2014, and posted to the FDA’s website Dec. ...