Elastic Therapy, LLC – FDA 483, Nov 14, 2025

Between November 12 and November 14, 2025, the U.S. Food and Drug Administration (FDA) conducted a regulatory inspection of the manufacturing facility of Elastic Therapy, LLC, located in Asheboro, North Carolina. This inspection was performed under the authority of the Federal Food, Drug, and Cosmetic Act to evaluate the firm's compliance with quality system standards. The primary concern identified during the site visit involved inadequate procedures for managing products that fail to meet predefined specifications. Specifically, the investigator noted that the company's internal protocols did not provide sufficient instructions for documenting or evaluating defects to determine if a formal investigation was necessary. A review of multiple nonconformance reports showed a lack of root cause analysis and impact evaluation. Furthermore, the firm lacked a statistical framework to guide the escalation of product issues into formal corrective or preventive action plans. Although management has expressed a commitment to resolving these issues, Elastic Therapy, LLC is responsible for performing thorough internal audits to identify and fix all violations. The company must submit a formal response to the FDA detailing its corrective actions and any objections to the findings presented in this report.