# China NMPA Inspection - Tianjin Jinzhang Technology Development Co., Ltd. - September 25, 2020

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-jinzhang-technology-development-co-ltd/6e7286ba-68eb-42bc-86ba-f6f482f8ef19
Source feed: China

> China NMPA unannounced inspection for Tianjin Jinzhang Technology Development Co., Ltd. published September 25, 2020. The National Medical Products Administration (NMPA) conducted an unannounced inspection of Tianjin Jinzhang Technology Development Co., Ltd. prior to 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 64 of 2020 from the National Medical Products Administration regarding the suspension of production and rectification of Tianjin Jinzhang Technology Development Co., Ltd.
- Company Name: Tianjin Jinzhang Technology Development Co., Ltd.
- Publication Date: 2020-09-25
- Product Type: devices
- Summary: The National Medical Products Administration (NMPA) conducted an unannounced inspection of Tianjin Jinzhang Technology Development Co., Ltd. prior to September 23, 2020. This inspection uncovered significant deficiencies within the company's quality management system, indicating non-compliance with the *Good Manufacturing Practice for Medical Devices*. Major violations included critical production management issues, specifically the absence of traceable production records for disposable MacConkey agar medium (batch 112506072), which severely compromised product traceability. In quality control, several finished product inspection reports were found to be inconsistent with registered technical requirements. For instance, disposable gentamicin agar medium (batch 12243108) lacked testing for non-O1 group Vibrio cholerae, while acidic Roche medium (batch 190416) and disposable modified Roche medium (batch 190418) omitted testing for Mycobacterium scrofula. Additionally, the company failed to maintain traceable records for its quality control strain usage, making it impossible to verify specific strains and passage information utilized in daily quality inspections. As a result, the NMPA has instructed Tianjin Jinzhang Technology Development Co., Ltd. to immediately suspend production for comprehensive rectification. The company must also assess product safety risks and initiate recalls for any products deemed unsafe, adhering to the *Regulations on the Recall of Medical Devices*. Resumption of production is strictly conditional upon passing a re-inspection by the Tianjin Municipal Drug Administration. The NMPA will conduct rigorous follow-up inspections to ensure compliance and will impose severe penalties for any further violations of the *Regulations on the Supervision and Administration of Medical Devices*.

Company: https://www.globalkeysolutions.net/companies/tianjin-jinzhang-technology-development-co-ltd/4fcbf13c-f0b0-402e-92e2-821c35236291