CMIC Pharma Science Co., Ltd. – FDA 483, Sep 3, 2026
An FDA inspection of CMIC Pharma Science Co., Ltd. in Ishikari, Japan, a control testing laboratory, revealed a significant issue regarding the lack of scientific justification for temperature probe placement. The firm failed to properly document worst-case locations within temperature-controlled environments used for testing, storage, and handling of Active Pharmaceutical Ingredients. This indicates a deficiency in their written program for routine calibration and performance assurance of equipment.
ID · cbe848fb-22e6-45e5-b956-8ca2d29c5521
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