Jiangsu Tohope Pharmaceutical Co., Ltd.August 31, 2018

FDA 483 - Jiangsu Tohope Pharmaceutical Co., Ltd. - August 31, 2018

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Record Details

An FDA inspection of JIANGSU TOHOPE PHARMACEUTICAL CO., LTD. in CHANGCHUN CITY, JIANGSU, CHINA, identified a significant issue with quality control procedures. The firm failed to ensure proper calibration entries for a pH meter used in the testing of Alpha Lipoic Acid, indicating a lapse in instrument control and record-keeping. This suggests a moderate severity issue related to quality system deficiencies.

Company: Jiangsu Tohope Pharmaceutical Co., Ltd.
Inspection Date: August 31, 2018
Product Type: Other
Office: Division of Human and Animal Food Operations - East IV
Person: Jose E. Perez-Soto

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ID · 90ffc530-c715-4cd2-883b-71f9c18fe1f1