China NMPA Drug Inspection - Kaifeng Municipal Institute of Medical Sciences - Bai Dian Ning Wan

The Henan Provincial Food and Drug Administration conducted supervision and sampling inspections across Henan Province as part of its 2016 Drug Sampling Inspection Work Plan. An announcement on August 3, 2016, revealed that 23 batches of drugs and traditional Chinese medicine pieces failed quality standards. Companies implicated included Henan Qingshan Pharmaceutical Co., Ltd., Zhengzhou Ruilong Pharmaceutical Co., Ltd., Maoming Junbang Traditional Chinese Medicine Pieces Co., Ltd., and others.

Key violations varied but frequently involved issues such as excessive sulfur dioxide residue, inaccurate total ash content, unacceptable moisture levels, and failures in content determination for active ingredients like Emodin and Cinnabar. Furthermore, several oral solutions failed microbial limits tests, and some products contained unapproved dyes, including Tartrazine and Carmine, or did not meet dissolution time specifications. These deficiencies indicate a failure to adhere to established quality and safety standards, potentially compromising public health.

In response, the Henan Provincial Food and Drug Administration mandated local authorities to investigate and take action against these violations, strictly in accordance with the "Drug Administration Law of the People's Republic of China" and other relevant regulations. This is to ensure accountability and the implementation of necessary corrective measures to protect public medication safety.