# FDA 483 - Chongqing Bioland Pharmaceutical Ltd. - January 13, 2025

Source: https://www.keypedia.com/records/483/chongqing-bioland-pharmaceutical-ltd/d59eb35c-6492-4409-9d5a-c89d6cf7abe8

> FDA 483 for Chongqing Bioland Pharmaceutical Ltd. on January 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chongqing Bioland Pharmaceutical Ltd.
- Inspection Date: 2025-01-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Chongqing Bioland Pharmaceutical Ltd, a non-sterile API manufacturer in Chongqing, China, was cited for significant deficiencies across laboratory controls, facilities, and equipment. Observations included inadequate analytical method transfer and testing procedures, incomplete laboratory records due to discarded raw data, and insufficient monitoring and calibration of the (b) (4) water system. Additionally, the firm lacked scientific rationale for environmental monitoring in clean rooms and had facility design flaws that could lead to API contamination.

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)

Company: https://www.keypedia.com/companies/chongqing-bioland-pharmaceutical-ltd/2f4210cd-bacb-41e2-bc87-fe70b13d1bdf

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