# FDA 483 - Zhejiang Lepu Pharmaceutical Co., Ltd. - December 07, 2018

Source: https://www.globalkeysolutions.net/records/483/zhejiang-lepu-pharmaceutical-co-ltd/df3d9da8-596e-42a2-8bae-17bf67ebca4d

> FDA 483 for Zhejiang Lepu Pharmaceutical Co., Ltd. on December 07, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Lepu Pharmaceutical Co., Ltd.
- Inspection Date: 2018-12-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zhejiang Lepu Pharmaceutical Co., Ltd. in Taizhou City, China, was inspected by the FDA from December 3-7, 2018. The inspection revealed significant deficiencies in laboratory controls, specifically regarding the validation of test procedures for Active Pharmaceutical Ingredients (API). Additionally, the firm failed to store drug products under appropriate temperature conditions, potentially affecting their quality.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.globalkeysolutions.net/companies/zhejiang-lepu-pharmaceutical-co-ltd/3f04f71b-33ea-46db-b25c-d115b2c88686

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