# China NMPA Inspection - Loudi Minkang Pharmaceutical Co., Ltd. - January 25, 2019

Source: https://www.globalkeysolutions.net/records/china_inspection/loudi-minkang-pharmaceutical-co-ltd/90434039-a8c2-49a2-9e84-15f66a20a137/
Source feed: China

> China NMPA unannounced inspection for Loudi Minkang Pharmaceutical Co., Ltd. published January 25, 2019. An unannounced inspection of Loudi Minkang Pharmaceutical Co., Ltd. was conducted by the National Medical Products Administration Audit and Inspection

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Loudi Minkang Pharmaceutical Co., Ltd.
- Company Name: Loudi Minkang Pharmaceutical Co., Ltd.
- Publication Date: 2019-01-25
- Product Type: Drugs
- Summary: An unannounced inspection of Loudi Minkang Pharmaceutical Co., Ltd. was conducted by the National Medical Products Administration Audit and Inspection Center from August 21 to August 23, 2018, as part of the National Drug Distribution Enterprise Annual Inspection Plan. The inspection revealed multiple critical violations of the "Good Supply Practice for Pharmaceutical Products". Significant issues included inadequate personnel qualifications, with the quality manager possessing an expired pharmacist registration and the quality department head lacking a required certificate. The company exhibited poor system access control, as a departed salesperson's computer permissions remained active, and its organizational structure was inconsistent, listing unapproved departments in records. Major deficiencies were found in temperature management. The cool storage and cold storage alarm system was misconfigured, sending alerts to a former employee, and monitoring terminals lacked calibration and maintenance. Cool storage facilities frequently operated outside acceptable temperature ranges without corrective action. Furthermore, both refrigerated trucks and insulated boxes failed to provide real-time temperature data collection, display, or transmission during transport. Annual full-load verification for cold storage, refrigerated trucks, and insulated boxes was not performed in 2017. Data backup practices were also insufficient, relying solely on the server host. As a result of these serious non-compliances, the Hunan Provincial Drug Administration revoked Loudi Minkang Pharmaceutical Co., Ltd.'s "Good Supply Practice for Pharmaceutical Products" certification. The company is currently under investigation for suspected illegal and irregular business practices.

Company: https://www.globalkeysolutions.net/companies/loudi-minkang-pharmaceutical-co-ltd/f770f936-ca6a-4ead-abed-92d0eaf563a0/