# FDA 483 - Shanghai SynTheAll Pharmaceutical Co., Ltd. - November 30, 2018

Source: https://www.keypedia.com/records/483/shanghai-syntheall-pharmaceutical-co-ltd/417c14d3-4e42-45cc-b2e2-a47f5bc81ee7

> FDA 483 for Shanghai SynTheAll Pharmaceutical Co., Ltd. on November 30, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai SynTheAll Pharmaceutical Co., Ltd.
- Inspection Date: 2018-11-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection of STA Pharmaceutical Co., Ltd. in Jinshan District, Shanghai, FDA investigators observed a significant quality control issue. A critical study to determine the potential of a starting material used in API manufacture was not completed until after the API had already been manufactured and distributed for Phase clinical trials. The study ultimately concluded the material was a weak substance, indicating a potential risk to product quality and patient safety.

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## Related Officers

- [Joel D. Hustedt](https://www.keypedia.com/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.keypedia.com/companies/shanghai-syntheall-pharmaceutical-co-ltd/fa409b87-68e2-4a70-bda1-c33e8d807977

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1