# FDA 483 - Shandong Ruiying Pioneer Pharmaceutical Co., Ltd - March 18, 2019

Source: https://www.keypedia.com/records/483/shandong-ruiying-pioneer-pharmaceutical-co-ltd/52038d75-de94-439b-bb4e-2c201838962f

> FDA 483 for Shandong Ruiying Pioneer Pharmaceutical Co., Ltd on March 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shandong Ruiying Pioneer Pharmaceutical Co., Ltd
- Inspection Date: 2019-03-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Shandong Ruiying Pioneer Pharmaceutical Co., Ltd. in Heze City, China, from March 18-22, 2019, revealed two significant observations. The firm was cited for inadequate qualification of equipment used in API manufacturing. Additionally, deficient warehouse cleaning practices were observed, including rust, heavy dust accumulation, and a lack of cleaning records.

## Related Officers

- [Professor](https://www.keypedia.com/people/liming-zhang/6c93b721-8725-4d87-8a42-254f3de5e49d)

Company: https://www.keypedia.com/companies/shandong-ruiying-pioneer-pharmaceutical-co-ltd/574c4f09-5a4e-4428-b84d-cb139c05ff9b

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