# FDA 483 - Jiangsu NHWA Pharmaceutical Co., Ltd. - April 05, 2019

Source: https://www.globalkeysolutions.net/records/483/jiangsu-nhwa-pharmaceutical-co-ltd/01f43592-fa59-4ca7-aae6-d29fa3e81f75

> FDA 483 for Jiangsu NHWA Pharmaceutical Co., Ltd. on April 05, 2019. 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: 2019-04-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Jiangsu Nhwa Pharmaceutical Co., Ltd, an API manufacturer in Xuzhou, China, received a Form 483 for multiple significant deficiencies. The inspection revealed issues with scientifically unsound stability testing procedures and inadequate investigations into product failures and complaints. Additionally, the firm's laboratory investigation procedures, API reprocessing system, and laboratory instrument control software validation were found to be insufficient.

## Related Documents

- [WARNING_LETTER - 2019-04-05](https://www.globalkeysolutions.net/records/warning_letter/jiangsu-nhwa-pharmaceutical-co-ltd/778847ce-c605-444a-b4c2-105a56eecf60)
- [483 - 2023-09-01](https://www.globalkeysolutions.net/records/483/jiangsu-nhwa-pharmaceutical-co-ltd/39f32da0-b7e1-490e-b123-aec0a446db2e)

## Related Officers

- [Christopher S. Keating](https://www.globalkeysolutions.net/people/christopher-s-keating/94fcfd32-feb5-4b6c-80da-16202f4be01d)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1