# FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) - Unknown Date

Source: https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/57f68425-186a-46f7-be58-9d26c4aa513d

> FDA 483 for Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) in Jinan, China, revealed critical deficiencies across its manufacturing operations for sterile and non-sterile drug products. The firm failed to establish and follow adequate procedures to prevent microbiological contamination, lacked proper validation of aseptic processes, and exhibited significant issues with environmental monitoring and discrepancy investigations. These widespread quality control failures indicate a high risk to product sterility and overall drug quality.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/d67404c0-879f-4dd4-8407-58d014e644e8)
- [483 - 2015-05-19](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/537a5a2e-46c6-42b0-a116-3a7c6a18817d)
- [483 - 2017-09-20](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/3d7aec8f-e0dc-4b88-82af-40bed46c9b2f)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/qilu-pharmaceutical-co-ltd-high-tech-zone-site/94263442-b5c4-4df8-b563-30ae0b9a4206

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