From May 10 to 15, 2026, the Shandong Provincial Drug Administration inspected Line 103 of the lyophilized powder injection workshop at Shandong Huatai Pharmaceutical, concluded that there was 1 serious defect and that the results were non-compliant, and decided to suspend production of amiodarone hydrochloride injection.
Evidence EVIDENCE
Sources 2 · Archived 0
SourceTypeReliabilityLink
华夏时报（网易转载）
2026-10-09 18:07 · 企业对生产过程中发生的偏差调查评估不充分，偏差发生后未全面评估质量风险，风险管控及处置措施不够完善，判定存在1项严重缺陷，综合评定结论为不符合要求。
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澎湃新闻（凤凰网转载）
2026-10-09 18:07 · 6月9日，国家组织药品联合采购办公室（简称“联采办”）发布公告，根据2026年6月9日山东省药监局药品生产监督检查结果通告，山东北大高科华泰制药有限公司（简称“华泰制药”）的盐酸胺碘酮注射液生产线存在严重缺陷，评定结论为不符合要求，涉事生产线已被暂停生产。
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Context CONTEXT
Cause
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This event
Shandong Drug Administration Finds Serious Defects at Huatai Pharmaceutical's Lyophilized Powder Injection Line, Suspends Production of Amiodarone Hydrochloride Injection
2026.05.10 · Official claim
Effect
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