China NMPA Drug Inspection - Hubei Minkang Pharmaceutical Co., Ltd. - Eriocaulon

The Fujian Province Drug Quality Bulletin (2018, Issue 2), published on July 16, 2018, details the outcomes of recent drug quality supervision and sampling inspections. Conducted under the regulatory authority of the "Drug Administration Law of the People's Republic of China," the inspections aimed to uphold drug quality and public health. A total of 20 drug batches were identified as non-compliant with standards outlined in the Chinese Pharmacopoeia (2010 and 2015 editions).

Key issues included deficiencies in various aspects of drug quality. For instance, Zhejiang Zhebei Pharmaceutical Co., Ltd. had multiple batches of Cetirizine Hydrochloride Tablets failing dissolution tests, while Hubei Hepu Pharmaceutical Co., Ltd.'s Azithromycin for Injection failed moisture content specifications. Several manufacturers of Traditional Chinese Medicine (TCM) products, such as Hebei Chufeng Traditional Chinese Medicine Pieces Co., Ltd. and Sinopharm Group Feng Lexing (Foshan) Medicinal Herbs Co., Ltd., faced violations related to properties, appearance, identification, impurities, sulfur dioxide residue, or ash content. These findings indicate widespread quality control failures across different product types.

In response to these violations, food and drug administration departments at all levels are actively investigating and processing the non-compliant drugs and implicated manufacturing units according to legal provisions. This requires the responsible companies to implement corrective actions and face potential regulatory enforcement.