# FDA 483 - Chongqing Daxin Pharmaceutical Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/chongqing-daxin-pharmaceutical-co-ltd/5d609919-e31b-46ca-9028-820353b31a8b

> FDA 483 for Chongqing Daxin Pharmaceutical Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chongqing Daxin Pharmaceutical Co., Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Chongqing Daxin Pharmaceutical Co., Ltd. in Chongqing, China, revealed two significant issues. The firm failed to follow written procedures for cleaning equipment used in API manufacturing, as evidenced by visually unclean equipment marked as "Cleaned." Additionally, there was a lack of temperature monitoring instruments in rooms used for the packaging process of APIs, which is critical for maintaining product storage conditions.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)

Company: https://www.keypedia.com/companies/chongqing-daxin-pharmaceutical-co-ltd/41f80e0d-c994-41e7-aa3f-32c2aabcea04

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