China NMPA Drug Inspection - Hainan Meihua Xilin Biopharmaceutical Co., Ltd. - Sodium cefamandole for injection

The State Food and Drug Administration (SFDA) of China, on November 25, 2016, announced the findings of national drug sampling inspections, revealing 29 batches of substandard drugs from 25 pharmaceutical enterprises. Noteworthy companies implicated include Korla Longzhiyuan Pharmaceutical Co., Ltd. and Henan Kanghua Huaiqing Pharmaceutical Co., Ltd. The inspections uncovered a range of quality control deficiencies across various drug products. Violations encompassed critical aspects such as appearance, identification, content determination, and pharmaceutical properties like fill weight variation, dissolution rate, bacterial count, and microbial limits.

Operating under the regulatory framework of the 'Drug Administration Law of the People's Republic of China,' provincial food and drug administrations were instructed to implement immediate measures. These actions included ordering the affected companies to suspend production, halt sales, and recall the non-compliant products. Furthermore, enterprises are mandated to conduct thorough investigations into the root causes of these quality issues and implement targeted corrective actions. The SFDA also stipulated that legal proceedings should be initiated against the non-compliant companies, and all relevant information, including corrective actions, must be publicly disclosed to ensure industry transparency and accountability.