# FDA 483 - Hisun Pharmaceutical (Nantong) Co., Ltd. - July 12, 2024

Source: https://www.keypedia.com/records/483/hisun-pharmaceutical-nantong-co-ltd/562ab22b-99f9-4a2d-a4f2-ac08d4050811

> FDA 483 for Hisun Pharmaceutical (Nantong) Co., Ltd. on July 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hisun Pharmaceutical (Nantong) Co., Ltd.
- Inspection Date: 2024-07-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hisun Pharmaceutical (Nantong) Co., Ltd., an API manufacturer in Nantong City, China, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate change control for new sampling devices, insufficient deviation investigations leading to repeat sampling errors, and poor equipment cleaning and maintenance practices. Additionally, the inspection revealed a lack of adequate written procedures for equipment cleaning and release.

## Related Officers

- [company_representative](https://www.keypedia.com/people/david-chen/26ef8cc5-8d1b-43fb-88e7-e354f5aac977)
- [Donna P. Hahn](https://www.keypedia.com/people/donna-p-hahn/d37150a7-fae0-4ee8-bec9-44da015fe162)

Company: https://www.keypedia.com/companies/hisun-pharmaceutical-nantong-co-ltd/4cace88a-293f-46cb-bb3f-f89466b7412d

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