483
Shandong Luxi Pharmaceutical Co., Ltd.Shandong Luxi Pharmaceutical Co., Ltd. – FDA 483, Jul 24, 2019
Record Details
An FDA inspection of Shandong Luxi Pharmaceutical Co. Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in Heze City, China, revealed significant deficiencies in laboratory controls and data integrity. Observations included insufficient stability studies, inadequate maintenance of laboratory records and raw data, and a lack of proper procedures for electronic data review and system validation. These findings indicate a serious breakdown in the firm's quality control systems.
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