China NMPA Drug Inspection - Anhui Fukang Pharmaceutical Co., Ltd - Sodium chloride injection

This document, the "Ningxia Drug Quality Sampling Inspection Information Announcement (No. 16, 2017)", published by the Ningxia Food and Drug Administration on December 18, 2017, details the results of a regional drug quality sampling inspection program. Conducted throughout 2017, the initiative was part of the '2017 Regional Drug Sampling Inspection Work Plan,' involving drug regulatory departments and testing institutions across Ningxia. The inspection encompassed a total of 120 batches, representing 85 different varieties of drugs, including chemical drugs, antibiotics, traditional Chinese medicine, traditional Chinese medicine decoction pieces, and medical institution preparations. Various manufacturers and distribution points, such as Ningxia Qiyuan Pharmaceutical Co., Ltd., Ningxia Chunhongyuan Traditional Chinese Medicine Pieces Co., Ltd., and numerous pharmacies and hospitals, were subject to this oversight. The regulatory framework for assessment primarily relied on the "Chinese Pharmacopoeia 2015 Edition," supplemented by specific "Ministry of Health Drug Standards" and "National Drug Standards" relevant to each product. Crucially, all 120 batches of drugs examined were found to be compliant with the established quality and regulatory requirements. Consequently, the announcement reported no main violations or issues, and therefore, no specific corrective actions were required from any of the inspected entities or products.