483
AdDent, Inc.AdDent, Inc. – FDA 483, Dec 8, 2022
Record Details
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.
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