# FDA 483 - Shandong Anshun Pharmaceutical Co., Ltd. - November 16, 2020

Source: https://www.keypedia.com/records/483/shandong-anshun-pharmaceutical-co-ltd/fe9359f5-0288-407b-861c-6f57da18fbe8

> FDA 483 for Shandong Anshun Pharmaceutical Co., Ltd. on November 16, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shandong Anshun Pharmaceutical Co., Ltd.
- Inspection Date: 2020-11-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Shandong Anshun Pharmaceutical Co., Ltd., an API manufacturer in China, revealed significant issues with their quality control systems. The firm failed to follow its written stability program, resulting in stability tests not being performed by their planned due dates. Additionally, analysts in the QC Laboratory were found to be inadequately trained on analytical methods, leading to out-of-specification results due to analyst error.

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.keypedia.com/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

Company: https://www.keypedia.com/companies/shandong-anshun-pharmaceutical-co-ltd/875867c5-8c38-42a5-9308-4775215cc951

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