FDA 483 - Permobil Inc - April 16, 2026
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Permobil Inc. in Lebanon, TN, a contract manufacturer of Class II powered wheelchairs, was cited for significant deficiencies in its quality management system. The inspection revealed inadequate application of risk-based controls for nonconforming products, ineffective change control, failures in analyzing quality data feedback, and an insufficient Corrective and Preventive Action process. Additionally, the firm failed to adequately plan, monitor, and control its production and service provision, specifically regarding final and in-process inspections, leading to distribution of malfunctioning devices with safety hazards.
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ID · 578025f7-233a-481b-a047-e0d189e5bdca