# FDA 483 - JIANGSU GRAND XIANLE PHARMACEUTICAL CO., LTD - Unknown Date

Source: https://www.keypedia.com/records/483/jiangsu-grand-xianle-pharmaceutical-co-ltd/e7168545-50e8-44c8-9eee-805b89843059

> FDA 483 for JIANGSU GRAND XIANLE PHARMACEUTICAL CO., LTD on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JIANGSU GRAND XIANLE PHARMACEUTICAL CO., LTD
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of JIANGSU GRAND XIANLE PHARMACEUTICAL CO., LTD identified a significant deficiency related to the lack of adequate stability data for a critical intermediate material. The firm failed to provide sufficient data to support the retest date, with initial stability studies failing specifications and subsequent studies being unrepresentative or conducted prior to analytical method validation. This indicates a serious lapse in quality control and data integrity practices.

## Related Officers

- [Milva E. Meléndez](https://www.keypedia.com/people/milva-e-melendez/b6b4adcc-58c8-43d1-ab42-859ea06c7dc2)

Company: https://www.keypedia.com/companies/jiangsu-grand-xianle-pharmaceutical-co-ltd/5101210d-55f1-412f-a386-8ca8b06d27d1

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