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Home » Device Firm Questions FDA Inspection Process, Warning Letter
Device Firm Questions FDA Inspection Process, Warning Letter
June 9, 2006
The FDA issued a May 30 warning letter to Restorative Health Services of Nashville, Tenn., for current good manufacturing practices (cGMP) violations related to the firm’s cranial orthosis device — a “helmet” designed to prevent the continued development of an abnormally-shaped head.