China NMPA Drug Inspection - 11 manufacturing companies (preparation units) - A total of 14 batches of 5 varieties of drugs

In September 2020, the Shandong Provincial Drug Administration issued Announcement No. 19, detailing the results of its sixth drug quality sampling inspection for the year. This regulatory initiative, conducted under the administration's annual safety plan, evaluated pharmaceutical products across production, distribution, and usage sectors. The inspection identified 14 non-compliant drug batches involving five varieties produced by 11 different manufacturers and preparation units. Key violations centered on three areas: failures in physical property standards (often due to incorrect material species or improper storage), identification discrepancies affecting authenticity, and inadequate active ingredient levels during content determination. To address these risks, the regulatory body enforced immediate control measures, including sealing and seizing non-compliant stock, suspending sales, and initiating product recalls. The involved companies were subjected to severe penalties as dictated by pharmaceutical laws. Furthermore, the administration mandated that all affected enterprises conduct internal investigations to identify the root causes of these failures and implement comprehensive rectification measures to ensure future product safety and compliance with medicinal standards.