# China NMPA Inspection - Wuhan Keruidi Medical Supplies Co., Ltd. - May 14, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/wuhan-keruidi-medical-supplies-co-ltd/5a007a43-c5b3-4b3f-8957-ee0cb4f7e638/
Source feed: China

> China NMPA unannounced inspection for Wuhan Keruidi Medical Supplies Co., Ltd. published May 14, 2018. Wuhan Kerui Medical Supplies Co., Ltd. underwent an unannounced special inspection by the FDA NMPA from April 17-18, 2018, focusing on their Hemodialy

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Wuhan Kerui Medical Supplies Co., Ltd.
- Company Name: Wuhan Keruidi Medical Supplies Co., Ltd.
- Publication Date: 2018-05-14
- Product Type: Device
- Summary: Wuhan Kerui Medical Supplies Co., Ltd. underwent an unannounced special inspection by the FDA NMPA from April 17-18, 2018, focusing on their Hemodialysis Concentrate and Dry Powder products. The inspection, based on Good Manufacturing Practice for Medical Devices, revealed significant quality management deficiencies. Two serious violations included the inability to trace the source of over 14,000 PE drums used in Liquid B production. Additionally, the company failed to implement or document corrective actions for a previously identified issue of insufficient employee understanding of quality documents. Eight general deficiencies were also identified, highlighting poor clean area maintenance, lack of critical monitoring equipment like differential pressure gauges, inadequate record-keeping for clean area access, and unauthorized changes to the concentrated liquid production process. Further issues involved missing calibration requirements for equipment, outsourcing critical raw material testing to an unqualified entity, and failures in sample retention management, including missing samples and ledger discrepancies. An internal auditor also lacked proper certification. As a result, regulatory authorities mandated Wuhan Kerui Medical Supplies Co., Ltd. to immediately cease production and rectify all identified problems. The company must assess product safety risks, recall any hazardous products, and face legal consequences for violations. Production resumption is contingent upon complete rectification and passing a subsequent follow-up inspection.

Company: https://www.globalkeysolutions.net/companies/wuhan-keruidi-medical-supplies-co-ltd/d11f6d19-b823-40cc-a584-a84b2bb2a5cf/