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