# FDA 483 - Zhejiang Langhua Pharmaceutical Co. Ltd. - August 30, 2024

Source: https://www.keypedia.com/records/483/zhejiang-langhua-pharmaceutical-co-ltd/04398447-8cd1-4445-ba04-2b4ee29ce51e

> FDA 483 for Zhejiang Langhua Pharmaceutical Co. Ltd. on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Langhua Pharmaceutical Co. Ltd.
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zhejiang Langhua Pharmaceutical Co. Ltd., an API drug manufacturer, revealed significant deficiencies in laboratory controls and master batch production records. The firm failed to implement scientifically sound water sampling methods and lacked established time limits and detailed production instructions in their batch records, indicating potential quality control issues.

## Related Officers

- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [investigator](https://www.keypedia.com/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)

Company: https://www.keypedia.com/companies/zhejiang-langhua-pharmaceutical-co-ltd/ee17277b-cc6d-4835-83b4-e864fa1b802c

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