483
Ningbo Shuangcheng Pharmaceutical Co., LtdNingbo Shuangcheng Pharmaceutical Co., Ltd – FDA 483, Nov 3, 2023
Record Details
An FDA inspection of Ningbo Shuangcheng Pharmaceutical Co., Ltd. in Ningbo, China, revealed two significant observations. The firm's quality control unit was found to lack proper responsibility for approving procedures and specifications, particularly concerning change control for document revisions. Additionally, equipment and utensils were not cleaned at appropriate intervals, leading to visible residue on primary packaging equipment.
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ID · 6a2430c3-8a22-423a-a30a-23c6e43afc7d
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