FDA 483 - Wand Dental Inc. - December 21, 2023

An FDA inspection of Wand Dental Inc. in Roseland, NJ, a specification developer and complaint handler, revealed significant deficiencies in their quality system. The firm failed to adequately document corrective and preventive actions, specifically regarding the revalidation of sterilization processes for sterile, single-use handpieces. Additionally, procedures for receiving, reviewing, and evaluating customer complaints were not adequately established, leading to insufficient review of a complaint and failure to assess the need for a Medical Device Report.