483
Shanghai Anbison Lab Co., Ltd.Shanghai Anbison Lab Co., Ltd. – FDA 483
Record Details
During an inspection, Shanghai Anbison Lab Co., Ltd., an analytical laboratory in Xuhui District, Shanghai, was cited for two observations related to deficiencies in their in vitro drug release rate testing (IVRT) studies. The firm failed to retain reserve samples for IVRT studies and did not validate an analytical method used for analyzing IVRT drug product samples. These issues indicate significant concerns regarding data integrity and quality control in their testing processes.
- Product type
- drugs
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ID · 636a737e-5188-4b1e-9d1f-936ea74832e5
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