FDAnews Device Daily Bulletin

Oct. 2, 2012 | Vol. 9 No. 193

AireRx Warning Letter Cites Complaint Handling, Marketing

A Tennessee maker of wheelchair components received an FDA warning letter after the agency found problems with the company’s documentation and complaint-handling procedures. According to the July 27 letter, AireRx Healthcare did not evaluate complaints to determine if they represented MDR-reportable events.
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