# Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) – FDA 483, Jun 12, 2026

Source: https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/29452266-732f-432e-a667-3a65447eda2e

> FDA 483 for Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) on June 12, 2026. 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: 2026-06-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) in Jinan, China, revealed significant deficiencies in their drug manufacturing operations. Observations included inadequate qualification of critical manufacturing equipment, failure to establish and follow proper production and process controls, and insufficient laboratory controls for reference standards. These issues indicate a lack of assurance regarding the identity, strength, quality, and purity of drug products.

## Related Documents

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- [483 - 2013-07-18](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/4de1de8f-387e-477c-9cb4-ff22defa0cba) — date: July 18, 2013
- [483](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/d67404c0-879f-4dd4-8407-58d014e644e8)

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8