# FDA 483 - Hainan Shuangcheng Pharmaceuticals Co Ltd - April 24, 2019

Source: https://www.globalkeysolutions.net/records/483/hainan-shuangcheng-pharmaceuticals-co-ltd/61a2c06a-c751-409c-a965-9c86c6672c00

> FDA 483 for Hainan Shuangcheng Pharmaceuticals Co Ltd on April 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hainan Shuangcheng Pharmaceuticals Co Ltd
- Inspection Date: 2019-04-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hainan Shuangcheng Pharmaceuticals Co., Ltd. in Haikou City, China, revealed significant deficiencies. Observations included inadequate controls over computer systems for user privileges, insufficient environmental monitoring in aseptic processing areas, and a lack of proper training for personnel performing visual inspections. Additionally, procedures to prevent microbiological contamination of sterile drug products were not adequately established or followed.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)

Company: https://www.globalkeysolutions.net/companies/hainan-shuangcheng-pharmaceuticals-co-ltd/920c7235-0cdd-4c0a-884c-43e1f605c1c6

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