FDA 483 - Vynacron Dental Resins, Inc. - January 21, 2025

An FDA inspection of Vynacron Dental Resins, Inc. in Jackson, NJ, a manufacturer of dental resins, revealed significant deficiencies in their quality system procedures. The firm was cited for inadequate procedures related to design change control, complaint handling, document control, and Medical Device Reporting (MDR). These observations indicate a need for comprehensive improvements in their quality management system.