# FDA 483 - Qilu Pharmaceutical Co., Ltd. (Dongjia Site) - May 24, 2024

Source: https://www.globalkeysolutions.net/records/483/qilu-pharmaceutical-co-ltd-dongjia-site/b02ec5dd-7ed6-4bb1-93cb-44e68316c45f

> FDA 483 for Qilu Pharmaceutical Co., Ltd. (Dongjia Site) on May 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Pharmaceutical Co., Ltd. (Dongjia Site)
- Inspection Date: 2024-05-24
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Qilu Pharmaceutical Co., Ltd. (Dongjia Site) in Jinan, China, revealed significant deficiencies in their aseptic manufacturing operations. Observations included a lack of established procedures for preventing microbiological contamination, inadequate cleaning and maintenance protocols for equipment, and incomplete master production and control records. Additionally, the firm failed to properly qualify production equipment, raising concerns about the sterility and quality of their drug products.

## Related Officers

- [Zhouxi Wang](https://www.globalkeysolutions.net/people/zhouxi-wang/0d759e8d-49e3-49db-a0c2-7552be7edd23)
- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.globalkeysolutions.net/companies/qilu-pharmaceutical-co-ltd-dongjia-site/cc92034a-0571-4e14-b26d-03e2efd1cd97

Office: https://www.globalkeysolutions.net/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3