# FDA 483 - Jiangsu NHWA Pharmaceutical Co., Ltd. - September 01, 2023

Source: https://www.globalkeysolutions.net/records/483/jiangsu-nhwa-pharmaceutical-co-ltd/39f32da0-b7e1-490e-b123-aec0a446db2e

> FDA 483 for Jiangsu NHWA Pharmaceutical Co., Ltd. on September 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu NHWA Pharmaceutical Co., Ltd.
- Inspection Date: 2023-09-01
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Jiangsu NHWA Pharmaceutical Co., Ltd., an API manufacturer in Xuzhou, Jiangsu, China, revealed significant deficiencies in its quality system. The firm failed to adequately investigate customer complaints regarding foreign particles in APIs and did not properly qualify its contract testing laboratories. Additionally, raw materials and APIs were not stored under appropriate temperature and humidity conditions, leading to multiple excursions.

## Related Documents

- [483 - 2019-04-05](https://www.globalkeysolutions.net/records/483/jiangsu-nhwa-pharmaceutical-co-ltd/01f43592-fa59-4ca7-aae6-d29fa3e81f75)
- [WARNING_LETTER - 2019-04-05](https://www.globalkeysolutions.net/records/warning_letter/jiangsu-nhwa-pharmaceutical-co-ltd/778847ce-c605-444a-b4c2-105a56eecf60)

## Related Officers

- [Alan P Kuretsberg](https://www.globalkeysolutions.net/people/alan-p-kuretsberg/8e138280-5c95-4714-a285-9e825b4c582d)
- [Eileen A. Liu](https://www.globalkeysolutions.net/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.globalkeysolutions.net/companies/jiangsu-nhwa-pharmaceutical-co-ltd/7b3402dc-1e72-471c-ba50-33f225ac6625

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4