China NMPA Drug Inspection - Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd. - Norfloxacin capsules

The National Drug Quality Bulletin (2011, Issue 1, Serial No. 85), published by the State Food and Drug Administration (now NMPA) on April 28, 2011, details the findings of nationwide drug quality sampling inspections. These inspections were conducted to enhance drug supervision and safeguard public health, covering 4035 batches of 55 drug varieties, including 18 national essential medicines. The overall quality was reported as good, with 4016 batches meeting standards, but 19 batches were found to be non-compliant.

The primary violations identified were related to content assay or content determination. Specifically, Hefei Jinyue Pharmaceutical Co., Ltd. and Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd. each had one batch of Norfloxacin capsules fail the content assay. Additionally, five batches of Xiaoyao Pills (Granules) from Sichuan Shangshantang Pharmaceutical Co., Ltd., Shijiazhuang Haitian Pharmaceutical Co., Ltd., Shangqiu Jinma Pharmaceutical Co., Ltd. (two batches), and Gansu Hexi Pharmaceutical Co., Ltd. failed content determination.

While the bulletin does not outline specific immediate actions for the implicated companies, such non-compliance typically requires the manufacturers to undertake thorough investigations, implement corrective and preventive measures, and may lead to regulatory enforcement actions to resolve manufacturing deficiencies and ensure future product integrity and public safety.