# FDA 483 - Shaanxi Hanjiang Pharmaceutical Group Co., Ltd (Gaoxin site) - September 18, 2023

Source: https://www.globalkeysolutions.net/records/483/shaanxi-hanjiang-pharmaceutical-group-co-ltd-gaoxin-site/d66ee45e-1e72-4f38-9d07-93784a1b2d0a

> FDA 483 for Shaanxi Hanjiang Pharmaceutical Group Co., Ltd (Gaoxin site) on September 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shaanxi Hanjiang Pharmaceutical Group Co., Ltd (Gaoxin site)
- Inspection Date: 2023-09-18
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. in Hanzhong City, China, an animal drug API manufacturer, was cited for four observations during an FDA inspection. The inspection revealed deficiencies in laboratory OOS/OOT procedures, inadequate investigation of discrepancies like shipping complaints, insufficient detail in written procedures for cleaning and raw material sampling, and incomplete production records. These issues indicate a need for improved quality control and documentation practices.

## Related Officers

- [Youkeun Kim](https://www.globalkeysolutions.net/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/shaanxi-hanjiang-pharmaceutical-group-co-ltd-gaoxin-site/0a902df4-b8bc-4375-bea1-06d35fab1f1e

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4