# China NMPA Inspection - Guangxi Zhongsen Pharmaceutical Group Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-zhongsen-pharmaceutical-group-co-ltd/562c6634-2c98-461e-8b3a-54e84ee9f157/
Source feed: China

> China NMPA unannounced inspection for Guangxi Zhongsen Pharmaceutical Group Co., Ltd. published January 09, 2018. An unannounced compliance inspection of Guangxi Zhongsen Pharmaceutical Group Co., Ltd. was conducted from November 20th to November 21st, 2017. The i

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guangxi Zhongsen Pharmaceutical Group Co., Ltd.
- Company Name: Guangxi Zhongsen Pharmaceutical Group Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced compliance inspection of Guangxi Zhongsen Pharmaceutical Group Co., Ltd. was conducted from November 20th to November 21st, 2017. The inspection, based on the Good Manufacturing Practice for Medical Devices, revealed 12 deficiencies, including 3 critical and 9 general findings, highlighting systemic failures in the company's quality management.

Key violations included the absence of regulations for quality management training, complaint handling, purchaser qualification verification, and medical device traceability. The company also failed to maintain complete quality management records, such as detailed cold chain shipment tracking. Significant personnel issues were identified, with staff lacking proper training, being unaware of responsibilities, and falsifying training records. Storage facilities were found to be inadequate, with insufficient shelving, mixed storage of pharmaceuticals and medical devices, and incorrect product placement. Furthermore, a refrigerated truck lacked an essential alarm system.

Documentation failures extended to purchase and quality assurance agreements, which were incomplete and lacked crucial product details or stipulated quality responsibilities. A critical finding involved product misidentification, where packages labeled as arterial blood sample collectors contained uncertified products and incorrect sterile injection needles. The computer information system also had incomplete outbound verification records, lacking registration and date information.

As a result, the Guangxi Zhuang Autonomous Region Food and Drug Administration has ordered Guangxi Zhongsen Pharmaceutical Group Co., Ltd. to rectify these issues within a specified period. Follow-up inspections will be conducted, and the administration must report the company's progress to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/guangxi-zhongsen-pharmaceutical-group-co-ltd/087beca2-506e-4fbf-8854-9381d5bb8940/