# FDA 483 - Shanghai STA Pharmaceutical Product Co., Ltd. - June 28, 2024

Source: https://www.globalkeysolutions.net/records/483/shanghai-sta-pharmaceutical-product-co-ltd/a049d683-ffe8-417a-9c17-8cc85ae8b87c

> FDA 483 for Shanghai STA Pharmaceutical Product Co., Ltd. on June 28, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai STA Pharmaceutical Product Co., Ltd.
- Inspection Date: 2024-06-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shanghai STA Pharmaceutical Product Co., Ltd. in Shanghai was inspected and cited for significant deficiencies in quality control, production, and facility sanitation. Observations included inadequate investigation of out-of-specification results, lack of written procedures for critical process controls, and insufficient validation of fumigation procedures. These issues indicate a potential risk to drug product quality and purity.

## Related Documents

- [483 - 2021-10-22](https://www.globalkeysolutions.net/records/483/shanghai-sta-pharmaceutical-product-co-ltd/66f84ae1-1dfe-4c3d-8d89-537b9ac0cad5)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/shanghai-sta-pharmaceutical-product-co-ltd/9034196c-599f-4cad-b2bb-1acc9f1beb3b

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