# Shanghai Anbison Lab Co., Ltd. – FDA 483

Source: https://www.keypedia.com/records/483/shanghai-anbison-lab-co-ltd/636a737e-5188-4b1e-9d1f-936ea74832e5

> FDA 483 for Shanghai Anbison Lab Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai Anbison Lab Co., Ltd.
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/sripal-reddy-mada/5f6d3308-0728-4aa4-8a11-6b935c921643)

Company: https://www.keypedia.com/companies/shanghai-anbison-lab-co-ltd/1a20aa54-5ca7-4054-b747-b64362c5338e

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917