483
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) – FDA 483, Apr 13, 2018
Record Details
An FDA inspection of Jiangsu Hengrui Medicine Co., LTD., an API and Sterile Drug Manufacturer in Lianyugang, China, revealed two significant observations. The firm was cited for inadequate laboratory controls regarding raw material sampling plans and for insufficient controls over computer systems, leading to concerns about electronic data integrity and unauthorized deletion privileges.
- Inspection date
- April 13, 2018
- Product type
- drugs
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ID · 45fdb93b-9fe4-47f6-a5dc-a3e42f8fe357
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