# FDA 483 - Shanghai STA Pharmaceutical Product Co., Ltd. - October 22, 2021

Source: https://www.globalkeysolutions.net/records/483/shanghai-sta-pharmaceutical-product-co-ltd/66f84ae1-1dfe-4c3d-8d89-537b9ac0cad5

> FDA 483 for Shanghai STA Pharmaceutical Product Co., Ltd. on October 22, 2021. 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: 2021-10-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shanghai STA Pharmaceutical Product Co, Ltd, a contract manufacturer in Shanghai, was inspected by the FDA from October 18-22, 2021. The inspection revealed significant deficiencies in record-keeping practices, including a lack of cleaning records and insufficient second-person verification during weighing operations. Additionally, the firm failed to consistently conduct written investigations for quality deviations.

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## Related Officers

- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

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