# FDA 483 - Yichang Sanxia Pharmaceutical Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/yichang-sanxia-pharmaceutical-co-ltd/4dbc29a8-4bda-4e2f-ae1f-44d27a5b90af

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

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## Details

- Record Type: 483
- Company Name: Yichang Sanxia Pharmaceutical Co., Ltd.
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Yichang Sanxia Pharmaceutical Company, LTD, an Active Pharmaceutical Ingredient manufacturer, revealed deficiencies in quality assurance and documentation practices. The firm failed to assess stability for critical raw material changes and did not consistently follow good documentation practices for analytical records and incubation times. These observations indicate a need for improved quality system controls.

## Related Officers

- [Compliance Officer / Investigator](https://www.keypedia.com/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

Company: https://www.keypedia.com/companies/yichang-sanxia-pharmaceutical-co-ltd/087044cf-7161-49c8-8496-3c572bc277d0

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321