FDA 483 - Sinopep-Allsino Biopharmaceutical Co., Ltd. - April 18, 2016

An FDA inspection of Sinopep Jiangsu Inc. in Lianyungang, China, identified one observation. The firm's Quality Department failed to calibrate a Long Term Stability Chamber after its temperature settings were changed to meet ICH Guidelines, and also lacked clear requirements for equipment requalification/recalibration following major changes.