483
Shandong Ruiying Pioneer Pharmaceutical Co., LtdShandong Ruiying Pioneer Pharmaceutical Co., Ltd – FDA 483, Mar 18, 2019
Record Details
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.
- Inspection date
- March 18, 2019
- Product type
- drugs
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ID · 52038d75-de94-439b-bb4e-2c201838962f
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