FDA 483 - Elastic Therapy, LLC - November 14, 2025

An FDA inspection of Elastic Therapy, LLC in Asheboro, NC, conducted from November 12-14, 2025, identified a significant quality system deficiency. The firm's procedures for controlling non-conforming product were found to be inadequate. This included failures in documenting and evaluating nonconformances, conducting necessary investigations, and using statistical methodology to determine when to elevate issues to corrective or preventive actions.