483
Sinopep-Allsino Biopharmaceutical Co., Ltd.FDA 483 - Sinopep-Allsino Biopharmaceutical Co., Ltd. - April 18, 2016
Record Details
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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ID · 7f35b0e4-2222-4845-bf34-9a9033373806