# FDA 483 - Shandong Anhong Pharmaceutical Co., Ltd. - October 30, 2020

Source: https://www.globalkeysolutions.net/records/483/shandong-anhong-pharmaceutical-co-ltd/9f201cbb-010b-412d-b8a8-04838f3940ff

> FDA 483 for Shandong Anhong Pharmaceutical Co., Ltd. on October 30, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shandong Anhong Pharmaceutical Co., Ltd.
- Inspection Date: 2020-10-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shandong Anhong Pharmaceutical Co., Ltd. was cited for significant deficiencies in its manufacturing processes and quality control systems. Observations include inadequate cleaning and disinfection procedures, failure to follow sterile product contamination prevention protocols, and insufficient laboratory controls for impurity evaluation. These issues indicate a moderate to severe risk to product quality and patient safety.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/shandong-anhong-pharmaceutical-co-ltd/3b784225-cf8c-4bc5-a5ad-b5e47f484f59

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