FDA 483 - Ziemek Dental Laboratory, Inc. - December 19, 2019

Ziemek Dental Laboratory, Inc. in Tumwater, WA, a manufacturer of Class 2 dental implant abutments, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate procedures for complaint handling, purchasing controls, document control, equipment maintenance and installation, training, and device master record maintenance. These issues indicate a broad lack of adequately established and implemented procedures for critical manufacturing processes.