A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
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. The GMP Letter