# FDA 483 - CSPC Ouyi Pharmaceutical Co., Ltd. - May 17, 2019

Source: https://www.keypedia.com/records/483/cspc-ouyi-pharmaceutical-co-ltd/5cf2568f-ab81-46f8-84b1-3550d3ddb29a

> FDA 483 for CSPC Ouyi Pharmaceutical Co., Ltd. on May 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSPC Ouyi Pharmaceutical Co., Ltd.
- Inspection Date: 2019-05-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of CSPC Ouyi Pharmaceutical Co., Ltd. in Shijiazhuang, China, revealed that the firm's examination and testing procedures for drug products and in-process materials were inadequate. Specifically, the visual inspection process for tablets did not properly account for unique defects, and the standard operating procedure for tablet press post-processing lacked sufficient detail for defect detection. These issues indicate a moderate severity concern regarding quality control and product efficacy.

## Related Officers

- [Samina S. Khan](https://www.keypedia.com/people/samina-s-khan/ca3e266c-aa69-4c28-9901-d344e0c259fd)

Company: https://www.keypedia.com/companies/cspc-ouyi-pharmaceutical-co-ltd/aae55a77-8bde-45fc-a232-7b200c55ea54

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