# China NMPA Inspection - Hubei Kangda Pharmaceutical Development Co., Ltd. - June 28, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-kangda-pharmaceutical-development-co-ltd/0340595e-f3aa-46c2-9d36-7c324ff478ef/
Source feed: China

> China NMPA unannounced inspection for Hubei Kangda Pharmaceutical Development Co., Ltd. published June 28, 2018. An unannounced inspection by the National Medical Products Administration (NMPA) uncovered significant non-compliance at an unnamed enterprise. The in

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hubei Kangda Pharmaceutical Development Co., Ltd.
- Company Name: Hubei Kangda Pharmaceutical Development Co., Ltd.
- Publication Date: 2018-06-28
- Product Type: devices
- Summary: An unannounced inspection by the National Medical Products Administration (NMPA) uncovered significant non-compliance at an unnamed enterprise. The inspection found that the company's previous premises were under renovation and had been vacated in March 2018. All operational facilities and equipment had been relocated to a new address at 2nd Floor, Building 2, No. 83, Checheng South Road, Wuhan Economic and Technological Development Zone. Critically, this proposed new operational site had not received the necessary approval from the Hubei Provincial Food and Drug Administration, meaning the enterprise was not authorized to operate from its current location.

Under the regulatory framework involving the NMPA and the Hubei Provincial Food and Drug Administration, the enterprise is mandated to undertake specific corrective actions. Before resuming any production, the company must submit a detailed written report to the Hubei Provincial Food and Drug Administration. Production can only recommence after the Provincial Administration conducts an inspection and officially confirms that the new premises and operations fully comply with all regulatory requirements. Additionally, the Hubei Provincial Food and Drug Administration is responsible for promptly reporting the enterprise's compliance status and resumption of production details to the NMPA's medical device regulatory department, ensuring adherence to quality and safety standards.

Company: https://www.globalkeysolutions.net/companies/hubei-kangda-pharmaceutical-development-co-ltd/2a41efa8-ff2a-441c-940a-577ae59d618b/