FDA EIR - Dental Technologies Inc. - April 24, 2018

An FDA inspection of Dental Technologies Inc., a manufacturer of Class II dental medical devices such as cements and resins, was conducted from April 23-24, 2018. The inspection, performed under the Medical Device Quality System Inspection Technique (QSIT) and Compliance Program 7382.845, concluded as "No Action Indicated" (NAI), meaning no formal Form FDA 483 was issued. However, four significant observations were discussed with company management during the close-out meeting. Key issues included inadequate documentation on the Packaging Material Inspection Worksheet (GF-198), specifically lacking detailed requirements and measurements for incoming material inspections. There was also ambiguity in classifying defects on this worksheet, which could potentially lead to the acceptance of lots with major quality issues. Furthermore, the company lacked sufficient controls and studies to ensure the temperature stability of its Alpha-Dent/Alpha-Etch 37 product during shipment, as the existing accelerated aging study was considered inadequate to cover all potential temperature exposures. Lastly, the 2018 Internal Quality Audit schedule did not comply with the firm's procedural timelines for audits, though this error was corrected during the inspection. In response, management committed to improving documentation, revising inspectional criteria, and initiating a freeze/thaw study to address product stability concerns.