# FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site) - Unknown Date

Source: https://www.keypedia.com/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-dongjin-road-site/6a83eb5d-8c88-4934-b86a-ab09a2182318

> FDA 483 for Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Jiangsu Hengrui Pharmaceuticals CO. LTD. received a Form 483 with nine observations during an inspection from August 14-29, 2023. The observations highlight significant deficiencies across laboratory controls, aseptic processing, environmental monitoring, and batch recordkeeping, indicating a lack of robust quality systems for sterile drug product manufacturing. Issues include unrepresentative sampling, inadequate sterility testing procedures, rewritten logbook entries, turbulent airflow in aseptic areas, and insufficient contamination prevention and monitoring.

## Related Documents

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## Related Officers

- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.keypedia.com/companies/jiangsu-hengrui-pharmaceuticals-co-ltd-dongjin-road-site/91cc5f1a-20dc-4832-bbdf-0af7d9268c3b

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