# FDA 483 - Hebei Shengxue Dacheng Pharmaceutical Co., Ltd. - April 05, 2024

Source: https://www.globalkeysolutions.net/records/483/hebei-shengxue-dacheng-pharmaceutical-co-ltd/8576d1e0-1433-409c-a513-37b36c54d473

> FDA 483 for Hebei Shengxue Dacheng Pharmaceutical Co., Ltd. on April 05, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hebei Shengxue Dacheng Pharmaceutical Co., Ltd.
- Inspection Date: 2024-04-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hebei Shengxue Dacheng Pharmaceutical Co., Ltd. in Shijiazhuang, China, was issued a Form 483 with seven observations following an FDA inspection. The firm demonstrated significant deficiencies in laboratory controls, including inadequate stability testing methods and OOS investigations. Additionally, issues were noted with equipment qualification, process validation, drug substance storage conditions, and adherence to cleaning and maintenance procedures.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Investigator](https://www.globalkeysolutions.net/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)

Company: https://www.globalkeysolutions.net/companies/hebei-shengxue-dacheng-pharmaceutical-co-ltd/a3285866-186d-4118-a334-0aeb4f170055

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