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本刊讯日前,为加大体外诊断试剂类医疗器械产品的监管力度,北京市通州区食品药品监督管理局组织开展了体外诊断试剂产品生产和使用专项检查。执法人员在生产环节中重点检查了原料采购、生产工艺控制以及产品检验,使用环节中重点检查了采购渠道、进货查验以及储存条件。此次专项检查,共检查体外诊断试剂生产企业3家,
Recently, in order to intensify the supervision on the products of in vitro diagnostic reagents, the Tongzhou District Food and Drug Administration of Beijing organized special inspections on the production and use of in vitro diagnostic reagents. Law enforcement officers in the production process focused on checking the procurement of raw materials, production process control and product testing, the use of key links to check procurement channels, purchase inspection and storage conditions. The special inspection, a total of three in vitro diagnostic reagents manufacturer,