# China NMPA Inspection - Liaoning Yinyi Biotechnology Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/liaoning-yinyi-biotechnology-co-ltd/4833765f-9447-4168-96d4-6eb24685499c/
Source feed: China

> China NMPA unannounced inspection for Liaoning Yinyi Biotechnology Co., Ltd. published August 15, 2018. An unannounced inspection of Liaoning Yinyi Biotechnology Co., Ltd., conducted on July 12-13, 2018, identified multiple non-conformities with *Good Ma

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Liaoning Yinyi Biotechnology Co., Ltd.
- Company Name: Liaoning Yinyi Biotechnology Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: An unannounced inspection of Liaoning Yinyi Biotechnology Co., Ltd., conducted on July 12-13, 2018, identified multiple non-conformities with *Good Manufacturing Practice for Medical Devices* and its *Appendix for Implantable Medical Devices*. The inspection focused on the company's Drug-Eluting Balloon Catheter production.

Key issues highlighted deficiencies in several critical areas. Equipment management was lacking, with an unconfirmed current maintenance plan, incomplete usage records for major production machinery, and inadequate control over measuring instruments, including unmanaged pressure gauges and an incorrectly documented caliper specification. Furthermore, the air conditioning purification system lacked a required differential pressure gauge for monitoring.

Quality control procedures were found to be inconsistent, as evidenced by the use of an incorrect culture medium for initial contamination bacteria tests. The company also lacked a specific control procedure for reworking nonconforming intermediate products, despite its own "Nonconforming Product Control Procedure" stipulating rework. Aseptic processes showed gaps, with no specific verification records for personnel capacity in certain clean areas. Deficiencies extended to raw material and packaging management, including absent detailed records for primary packaging material selection, conflicting storage conditions for paclitaxel, and non-explosion-proof lighting in the analytical storage area. Finally, product sample retention regulations lacked specific provisions for the drug-eluting balloon product.

The Liaoning Provincial Food and Drug Administration has mandated the company to rectify all identified problems within a specified period. This includes assessing product safety risks and initiating product recalls for any potential hazards. Follow-up inspections are planned, and the provincial administration must report rectification progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/liaoning-yinyi-biotechnology-co-ltd/06bc8b44-6139-4abf-9aaf-141f2568c051/