# FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) - May 19, 2015

Source: https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/537a5a2e-46c6-42b0-a116-3a7c6a18817d

> FDA 483 for Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) on May 19, 2015. 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)
- Inspection Date: 2015-05-19
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: This FDA Form 483 was issued to Qilu Pharmaceuticals Co, Ltd in Jinan, Shandong Province, China, a finished dosage pharmaceutical manufacturer. The inspection revealed significant deficiencies across production, laboratory, and quality systems, including inadequate operator qualification, non-contemporaneous record-keeping, and insufficient controls for equipment, protective gear, and laboratory procedures. These observations indicate a lack of robust quality oversight and control in critical manufacturing and testing processes.

## Related Documents

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- [483 - 2017-09-20](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/3d7aec8f-e0dc-4b88-82af-40bed46c9b2f)
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## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Zachary A. Bogorad](https://www.keypedia.com/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)

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/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321