# China NMPA Inspection - Leica Biosystems Newcastle Ltd - December 14, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/leica-biosystems-newcastle-ltd/0c6b3ffd-8862-44e6-aab8-0c1ab9f0ad4d
Source feed: China

> China NMPA unannounced inspection for Leica Biosystems Newcastle Ltd published December 14, 2017. The State Food and Drug Administration (SFDA) of China, on December 14, 2017, announced the suspension of imports for the HER-2 Detection Kit (Immunoh

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 153 of 2017 from the State Administration for Market Regulation on the Suspension of Import of HER-2 Detection Kit (Immunohistochemical Method) from Leica Biosystems Newcastle Ltd, UK
- Company Name: Leica Biosystems Newcastle Ltd
- Publication Date: 2017-12-14
- Product Type: devices
- Summary: The State Food and Drug Administration (SFDA) of China, on December 14, 2017, announced the suspension of imports for the HER-2 Detection Kit (Immunohistochemical Method) manufactured by Leica Biosystems Newcastle Ltd, UK. This regulatory action stems from recent on-site inspections at the overseas production facility. The core issue identified was an unauthorized alteration in the suppliers of key raw materials, specifically mouse IgG and hydrogen peroxide, utilized in the HER-2 detection kit. This change was implemented without fulfilling the necessary regulatory protocols.

The SFDA concluded that Leica Biosystems Newcastle Ltd failed to comply with the stipulations of China's "Regulations for the Registration and Management of In Vitro Diagnostic Reagents." To uphold public safety in medical device usage, and in accordance with Article 55 of the "Regulations on the Supervision and Administration of Medical Devices" (State Council Decree No. 680), the SFDA mandated the immediate suspension of all imports of the affected HER-2 diagnostic kit. The announcement also indicated that further legal procedures would be pursued to address the non-compliance.

Company: https://www.globalkeysolutions.net/companies/leica-biosystems-newcastle-ltd/3b10b0b4-f38e-4093-b3e8-97aaf3e03c6b