# FDA 483 - Chongqing Southwest No 2 Pharmaceutical Factory Co., Ltd - May 27, 2024

Source: https://www.keypedia.com/records/483/chongqing-southwest-no-2-pharmaceutical-factory-co-ltd/32df5e9d-7727-4650-b1e8-70e65c73303c

> FDA 483 for Chongqing Southwest No 2 Pharmaceutical Factory Co., Ltd on May 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chongqing Southwest No 2 Pharmaceutical Factory Co., Ltd
- Inspection Date: 2024-05-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Chongqing Southwest No. 2 Pharmaceutical Factory Co. Ltd, an API manufacturer in Chongqing, China, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in reprocessing validation, investigation of out-of-specification results, water system monitoring for microbial contamination, and in-process control procedures. These issues indicate a lack of robust quality control and assurance for products distributed to the US market.

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/chongqing-southwest-no-2-pharmaceutical-factory-co-ltd/dbcf7c68-8b86-427d-90cd-92c27afcb7fa

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