FDA 483 - AdDent, Inc. - December 08, 2022

AdDent, Inc. in Danbury, CT, underwent an FDA inspection from December 6-8, 2022, which identified deficiencies in their finished device acceptance procedures. The firm released Calset Composite Warmers, a Class II device, that either lacked complete temperature testing records or had temperatures outside the specified acceptance range. This indicates a failure in quality control for product release.