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. Advanced OrthoPro’s process control procedure, titled “Helmet Mold Instructions,” was developed during the inspection and omitted critical criteria, such as documented workmanship standards, the letter notes.
Devices & Diagnostics Letter