China NMPA Inspection - Hunan Dongting Pharmaceutical Co., Ltd. - November 07, 2016

From August 30 to September 2, 2016, the Hunan Provincial Food and Drug Administration conducted unannounced inspections of eight drug distribution companies, including Hunan Zhonglian Pharmaceutical Co., Ltd. and Hunan Kangtian Pharmaceutical Co., Ltd. These inspections, part of a broader 2016 Drug Distribution Unannounced Inspection Plan, aimed to ensure adherence to Good Supply Practice (GSP) regulations.

Significant systemic issues were identified across the inspected entities. Common violations included widespread failures in documentation and record-keeping, such as incomplete sales records, lack of proper invoicing, and inadequate handling of substandard drugs. Many companies exhibited deficiencies in their quality management systems, with quality managers often unfamiliar with their responsibilities or lacking necessary qualifications. Operational problems included improper storage conditions, mixing of drug and non-drug products, and critical failures in temperature and humidity monitoring systems. Computer systems often had functional defects, such as not automatically locking expired customer licenses, or lacking standardized access control. Financial non-compliance, like using cash transactions for regulated drugs, and incomplete supplier qualification documents were also reported.

As a result, the GSP certification certificates for four companies—Hunan Zhonglian, Hunan Kangtian, Hunan Guancheng, and Hunan Danguiyuan—were revoked. Suspected illegal activities at these companies were transferred to municipal bureaus for further investigation and legal action. The remaining four companies, including Sinopharm Holding Changde Co., Ltd., were mandated to implement immediate rectification measures to address their respective compliance shortcomings.