# FDA 483 - Jiangsu Hansoh Pharmaceutical Group Co., Ltd - April 24, 2026

Source: https://www.keypedia.com/records/483/jiangsu-hansoh-pharmaceutical-group-co-ltd/bac320eb-cc86-4760-bb4b-a055b0e5125b

> FDA 483 for Jiangsu Hansoh Pharmaceutical Group Co., Ltd on April 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Hansoh Pharmaceutical Group Co., Ltd
- Inspection Date: 2026-04-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Jiangsu Hansoh Pharmaceutical Group Co. Ltd. in Lianyungang, Jiangsu, was inspected regarding its sterile drug manufacturing operations. The inspection revealed significant deficiencies across multiple areas, including inadequate validation of sterilization processes, insufficient investigation into discrepancies and complaints, and failures in environmental monitoring and equipment calibration. These issues indicate a lack of robust controls to prevent microbiological contamination and ensure product quality and sterility.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/jiangsu-hansoh-pharmaceutical-group-co-ltd/befa76f3-aa80-41d4-8db5-7f879f6a30e9)
- [483 - 2019-06-13](https://www.keypedia.com/records/483/jiangsu-hansoh-pharmaceutical-group-co-ltd/b4c214ad-3e91-4467-97b4-d9b4363be304)

## Related Officers

- [Investigator](https://www.keypedia.com/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)
- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8