483
Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site)Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site) – FDA 483, Jan 13, 2023
Record Details
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.
- Inspection date
- January 13, 2023
- Product type
- drugs
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ID · c1081f0a-ce3a-4083-8287-76e4214607a8
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