# FDA 483 - Shandong Xinhua Pharmaceutical Company Limited - March 25, 2019

Source: https://www.keypedia.com/records/483/shandong-xinhua-pharmaceutical-company-limited/c944c50e-057c-4ae8-b8ce-4de9d48b6efa

> FDA 483 for Shandong Xinhua Pharmaceutical Company Limited on March 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shandong Xinhua Pharmaceutical Company Limited
- Inspection Date: 2019-03-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shandong Xinhua Pharmaceutical Company Limited, an API manufacturer in Zibo, China, was inspected and found to have significant deficiencies across its quality system. The firm failed to adequately investigate out-of-specification results, maintain control over critical manufacturing and laboratory records, and properly implement corrective and preventive actions or change controls. Additionally, the quality unit demonstrated deficient oversight of laboratory electronic systems and data integrity practices.

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/shandong-xinhua-pharmaceutical-company-limited/7350901d-493e-45cb-a67f-c73093cf762e

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