China NMPA Drug Inspection - Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. - Gallopropyl ester for injection

On March 14, 2016, China's State Administration for Market Regulation (NMPA) issued Announcement No. 54, revealing critical quality deficiencies identified during national drug sampling inspections. The announcement detailed that 36 batches of drugs from 29 pharmaceutical companies, including Suzhou Zhonghua Pharmaceutical Industry Co., Ltd., were found to be substandard.

Prominent issues included quality failures in products such as Itraconazole capsules from Suzhou Zhonghua, Meclofenac Hydrochloride for Injection from Nanjing Haichen Pharmaceutical Co., Ltd., and Gastrodia elata headache tablets from Harbin Renhuang Pharmaceutical Co., Ltd. The non-compliant aspects spanned critical quality attributes, including dissolution rate, presence of related substances, bacterial count, solution clarity, visible foreign matter, disintegration time, moisture content, and variations in fill volume and weight, indicating significant manufacturing control problems.

Under the NMPA's regulatory authority, provincial food and drug administrations in 16 regions were mandated to take immediate action. This involved requiring the affected enterprises to suspend production and sales, initiate product recalls, and conduct comprehensive investigations into the root causes of the quality deviations. Companies were also instructed to address these issues legally, with results of investigations and handling required to be publicly disclosed by May 31, 2016, and reported back to the NMPA.