# FDA 483 - Ningxia Qiyuan Pharmaceutical Co., Ltd. - September 12, 2025

Source: https://www.globalkeysolutions.net/records/483/ningxia-qiyuan-pharmaceutical-co-ltd/27882229-6689-4914-b065-11615aa88d35

> FDA 483 for Ningxia Qiyuan Pharmaceutical Co., Ltd. on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ningxia Qiyuan Pharmaceutical Co., Ltd.
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Ningxia Qiyuan Pharmaceutical Co., Ltd. in Yinchuan, China, an API manufacturer, revealed significant deficiencies in their equipment cleaning procedures. The firm's cleaning protocols lacked sufficient detail, failing to establish critical parameters like maximum time between processing and cleaning, clean hold times, and methods to prevent contamination. These issues raise concerns about the reproducibility and effectiveness of their cleaning processes for API manufacturing.

## Related Documents

- [483 - 2019-06-25](https://www.globalkeysolutions.net/records/483/ningxia-qiyuan-pharmaceutical-co-ltd/f94bea60-ccfe-4962-946b-dd09d24728ae)

## Related Officers

- [Evan Tong](https://www.globalkeysolutions.net/people/evan-tong/2cd81562-886c-4672-9522-a07fb1b33ef2)
- [Pharmacist | Consumer Safety Officer](https://www.globalkeysolutions.net/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.globalkeysolutions.net/companies/ningxia-qiyuan-pharmaceutical-co-ltd/c3f60fce-9615-4bb0-96fb-7df0b3242164

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8