# FDA 483 - Livzon New North River Pharmaceutical Co., Ltd. - December 20, 2024

Source: https://www.globalkeysolutions.net/records/483/livzon-new-north-river-pharmaceutical-co-ltd/ad45afaf-9645-4f94-9c36-610869947a38

> FDA 483 for Livzon New North River Pharmaceutical Co., Ltd. on December 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Livzon New North River Pharmaceutical Co., Ltd.
- Inspection Date: 2024-12-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Livzon New North River Pharmaceutical Co., Ltd. identified significant deficiencies within its Quality Unit. The firm failed to adequately review and approve complete method validations for final product release, stability testing, and raw materials, and did not ensure appropriate testing of materials, particularly recovery solvents. Furthermore, the Quality Unit failed to investigate critical deviations related to retrospective analyses of method validations.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.globalkeysolutions.net/companies/livzon-new-north-river-pharmaceutical-co-ltd/49cdcdc8-9c6c-4486-b6cd-e404c21dd2d2

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8