# FDA 483 - Suzhou Homesun Pharmaceutical Co., Ltd. - April 12, 2019

Source: https://www.keypedia.com/records/483/suzhou-homesun-pharmaceutical-co-ltd/e202478c-cf07-4bd1-82b7-092d0ef1ce64

> FDA 483 for Suzhou Homesun Pharmaceutical Co., Ltd. on April 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suzhou Homesun Pharmaceutical Co., Ltd.
- Inspection Date: 2019-04-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Suzhou Homesun Pharmaceutical Co. Ltd. in Jiangsu, P.R. China, revealed numerous deficiencies in their manufacturing of active pharmaceutical ingredients (APIs). The firm was cited for poor facility and equipment maintenance, inadequate material identification and storage, and significant gaps in documentation for critical operations, laboratory testing, and quality reviews. These issues indicate a lack of adherence to good manufacturing practices and robust quality control systems.

## Related Officers

- [Wilmary Negron Rodriguez](https://www.keypedia.com/people/wilmary-negron-rodriguez/e7bb04eb-ed58-4e4c-932d-1069c76c0215)

Company: https://www.keypedia.com/companies/suzhou-homesun-pharmaceutical-co-ltd/5809bc97-e193-4bf6-b26e-cd20bee95905

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