# China NMPA Inspection - Jiangsu Lianshui Pharmaceutical Co., Ltd. - July 21, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-lianshui-pharmaceutical-co-ltd/efffecee-e631-4fb3-aaf3-78712aa75e86/
Source feed: China

> China NMPA unannounced inspection for Jiangsu Lianshui Pharmaceutical Co., Ltd. published July 21, 2017. An unannounced inspection of Jiangsu Lianshui Pharmaceutical Co., Ltd., conducted from July 2-4, 2017, by the State Food and Drug Administration, reve

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangsu Lianshui Pharmaceutical Co., Ltd.
- Company Name: Jiangsu Lianshui Pharmaceutical Co., Ltd.
- Publication Date: 2017-07-21
- Product Type: Drugs
- Summary: An unannounced inspection of Jiangsu Lianshui Pharmaceutical Co., Ltd., conducted from July 2-4, 2017, by the State Food and Drug Administration, revealed significant deviations from the Good Manufacturing Practice for Pharmaceuticals (2010 Revision).

Key violations included severe cross-contamination risks due to the shared production of non-hormonal and hormonal products on the same lines without adequate evaluation or preventative measures. Cleaning validation was insufficient, and filter cartridges were reused across different product types and production areas without proper validation.

The inspection also identified critical data reliability issues. Material issuance records for ampoules were inconsistent with actual quantities, and light inspection records were incomplete and not timely. Furthermore, critical process parameters, such as water temperature in washing tanks, were reportedly estimated by touch rather than measured, indicating potential falsification of records. The company also failed to adhere to its own internal procedures by producing non-hormonal products in hormone-designated areas and neglected to report equipment malfunctions as deviations.

As a result of these serious findings, the company's Good Manufacturing Practice Certificate for small-volume injections (including hormones) has been revoked. Jiangsu Lianshui Pharmaceutical Co., Ltd. is required to conduct a comprehensive investigation and assessment of all products manufactured on the affected hormone production lines and implement necessary risk control measures, potentially including product recalls.

Company: https://www.globalkeysolutions.net/companies/jiangsu-lianshui-pharmaceutical-co-ltd/6cc0f2c2-d835-4a46-9b8f-6a4144a3282c/