# FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) - September 20, 2017

Source: https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/3d7aec8f-e0dc-4b88-82af-40bed46c9b2f

> FDA 483 for Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) on September 20, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)
- Inspection Date: 2017-09-20
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Qilu Pharmaceutical Co. Ltd. in Jinan, Shandong, China, revealed deficiencies in personnel monitoring during aseptic operations. Specifically, the procedure for taking operator finger samples after aseptic operations lacked sufficient detail, leading to inconsistent sampling practices. This indicates a concern regarding the control of aseptic processing environments.

## 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 - Unknown Date](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/57f68425-186a-46f7-be58-9d26c4aa513d)

## Related Officers

- [Lindsey M. Straney, Ph.D.](https://www.keypedia.com/people/lindsey-m-straney-phd/0a5d8f4c-b83b-4a3d-8a5a-d2b574cb66ed)
- [Marcilo B. Kentenbe, Cso](https://www.keypedia.com/people/marcilo-b-kentenbe-cso/92bede0f-5bd7-4530-b5c9-4461b376932d)

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