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.
Ningbo Huahui Medical Instruments was handed an FDA warning letter after telling investigators it lost its design documents for a digital thermometer last year. During an April 16-18 inspection at the Ningbo, China, plant, the company could not provide evidence that it completed design input, output verification or review of the thermometers. The company manufactures thermometers and blood pressure monitors. The GMP Letter