Sagemax Bioceramics, Inc. – FDA Warning Letter, Aug 18, 2014

On August 11-18, 2014, an FDA inspection of a firm manufacturing NexxZr T High Translucency Dental Zirconia and NexxZr S Highest Strength Dental Zirconia devices revealed adulterated and misbranded products. The devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to maintain Device Master Records (DMRs) (21 CFR 820.181):** DMRs lacked procedures for in-process/final batch numbering, furnace temperature specifications, shrinkage factor calculations, and raw zirconia powder composition analysis. The firm's response was inadequate, missing acceptance criteria for ring diameter, shrinkage factor procedures, and referenced revisions for QA testing results. 2. **Failure to establish incoming product acceptance procedures (21 CFR 820.80(b)):** No procedures for measuring chemical composition of raw zirconia powder or interpreting radioactivity results from a contract lab to meet ISO 13356:2008. The response for radioactivity interpretation was inadequate, lacking evidence of method equivalence to the ISO standard. 3. **Failure to control purchased products/services (21 CFR 820.50):** Purchasing procedures lacked requirements for controlling service suppliers, like analytical laboratories.