# FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) - April 13, 2018

Source: https://www.keypedia.com/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-jinqiao-road-site/45fdb93b-9fe4-47f6-a5dc-a3e42f8fe357

> FDA 483 for Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) on April 13, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)
- Inspection Date: 2018-04-13
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: 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.

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## Related Officers

- [Manager](https://www.keypedia.com/people/qin-xu/176a88a7-a11e-4374-a64a-378806e76d84)
- [investigator](https://www.keypedia.com/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)

Company: https://www.keypedia.com/companies/jiangsu-hengrui-pharmaceuticals-co-ltd-jinqiao-road-site/78556cbd-f0c8-40a5-a1f2-3ab0dce403ee

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3