# FDA 483 - Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site) - January 13, 2023

Source: https://www.keypedia.com/records/483/shandong-anxin-pharmaceutical-co-ltd-laoling-site/c1081f0a-ce3a-4083-8287-76e4214607a8

> FDA 483 for Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site) on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site)
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shandong Anxin Pharmaceutical Co., Ltd, an Active Pharmaceutical Ingredient manufacturer in Dezhou, Shandong, was cited for a significant quality system deficiency. The inspection revealed that the firm lacks a scientifically sound cleaning validation program for its active pharmaceutical ingredients. This includes failing to thoroughly assess the most difficult product to clean for non-dedicated equipment.

## Related Officers

- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.keypedia.com/companies/shandong-anxin-pharmaceutical-co-ltd-laoling-site/8ecae9ce-7b8b-40b5-99de-92a6859f9683

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