# FDA 483 - Jiangsu Hansoh Pharmaceutical Group Co., Ltd - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/jiangsu-hansoh-pharmaceutical-group-co-ltd/befa76f3-aa80-41d4-8db5-7f879f6a30e9

> FDA 483 for Jiangsu Hansoh Pharmaceutical Group Co., Ltd on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Hansoh Pharmaceutical Group Co., Ltd
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: JIANGSU HANSOH PHARMACEUTICAL GROUP CO.LTD in Lianyungang, China, was cited for significant deficiencies across its manufacturing and quality control operations during an FDA inspection. The observations highlight a systemic lack of adherence to aseptic processing controls, inadequate environmental monitoring, and insufficient documentation for cleaning, equipment qualification, and laboratory investigations. These issues indicate a moderate to severe risk to product quality and patient safety, particularly for sterile drug products.

## Related Documents

- [483 - 2019-06-13](https://www.globalkeysolutions.net/records/483/jiangsu-hansoh-pharmaceutical-group-co-ltd/b4c214ad-3e91-4467-97b4-d9b4363be304)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

Company: https://www.globalkeysolutions.net/companies/jiangsu-hansoh-pharmaceutical-group-co-ltd/05c8e8c4-3ef9-4644-9f70-ddabbded9eec

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd