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Reset Technology Corporation, which manufactures the ResetSmile Partial Denture Device and ResetSmile Impression Kit Device (dental devices), violated FDA Quality System Regulation requirements under 21 CFR Part 820. An FDA inspection conducted from October 29 through December 20, 2024, at the company's Englewood Cliffs, NJ facility identified failures in manufacturing controls, including inadequate process validation procedures where results could not be fully verified by subsequent inspection and testing. The devices were deemed adulterated due to non-conformity with current good manufacturing practice requirements, and the company's January 2025 response to the FDA's inspectional observations was found insufficient to address the violations.