Chinese Thermometer Plant Warned After ‘Losing’ Design Documents

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