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

Source: https://www.globalkeysolutions.net/records/483/jiangsu-hansoh-pharmaceutical-group-co-ltd/98730089-453d-4cc3-909d-2967504ae1c4

> 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: International Compliance Team
- Summary: An FDA inspection of Lianyungang Hongchuang Pharmaceutical Co. Ltd. in Lianyungang, China, an API manufacturer, revealed significant deficiencies. Observations included manufacturing equipment with corrosion and chipped surfaces, which is used for sterile injectable drug products. Additionally, the firm's Master Batch Records lacked complete instructions for critical production steps.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/elizabeth-l-edwards/a1d73c1b-384d-4e59-bd6c-68cfa520c020)

Company: https://www.globalkeysolutions.net/companies/jiangsu-hansoh-pharmaceutical-group-co-ltd/300d3bc8-8bd8-4257-b12f-4cce9a6c1f28

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321