FDAnews Device Daily Bulletin

June 14, 2012 | Vol. 9 No. 117

Indianapolis Helmet Maker Warned on Records, Procedural Flaws

The FDA has cited a manufacturer of cranial remodeling helmets on seven areas of documentation and policy flaws. Indianapolis-based Advanced OrthoPro received the May 18 warning letter from the FDA’s Detroit District Office following an April 16–26 inspection. According to the letter, the company lacked a written process control procedure that would ensure its helmets meet specifications.
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