# FDA 483 - Sichuan Deebio Pharmaceutical Co., Ltd. - September 08, 2023

Source: https://www.globalkeysolutions.net/records/483/sichuan-deebio-pharmaceutical-co-ltd/2fc36338-e809-44c5-b0c5-c38f97c7f359

> FDA 483 for Sichuan Deebio Pharmaceutical Co., Ltd. on September 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sichuan Deebio Pharmaceutical Co., Ltd.
- Inspection Date: 2023-09-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sichuan Deebio Pharmaceutical Co. Ltd. in Guanghan, China, was cited for significant deficiencies in laboratory controls, quality unit responsibilities, and production processes during an FDA inspection. The observations highlight issues with data integrity, inadequate investigations, and a lack of validated procedures for manufacturing, cleaning, and distribution of active pharmaceutical ingredients. These findings indicate a serious lack of control over critical aspects of drug substance quality and compliance.

## Related Documents

- [483 - 2023-09-08](https://www.globalkeysolutions.net/records/483/sichuan-deebio-pharmaceutical-co-ltd/b767f37b-69c4-44de-9b55-92019a153907)

## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Anders Evenson](https://www.globalkeysolutions.net/people/anders-evenson/a37224ef-88c8-47ed-83ba-421695dd2228)

Company: https://www.globalkeysolutions.net/companies/sichuan-deebio-pharmaceutical-co-ltd/45f37698-bc0d-45b3-a46e-9243d9625e5c

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