Tagged: CFDA, Drug, on-site inspection
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February 10, 2015 at 3:00 am #586
China Drug ConsultingKeymaster
Recently, the media reported that a clinic in Changchun city found a bottle of injection have the “hair” alike visible particles problem. Jilin Food and Drug Administration are carrying out in-depth investigation. China Food and Drug Administration (CFDA) paid high attention to the quality and safety issues, and sent investigation teams to Changchun and the drug manufacturer to verify the circumstances of product and patients. The investigation teams have conducted a comprehensive on-site inspection for the production enterprise of Shandong Qidu Pharmaceutical Co., Ltd.
After investigation, the product named Levofloxacin Hydrochloride and Sodium Chloride Injection was produced by Shandong Qidu Pharmaceutical Co., Ltd. (Strength 100ml, package glass bottle, batch number C13042201, production date April 22, 2013). According to the relevant provisions of the risk and recall measures, Shandong Qidu Pharmaceutical Co., Ltd. has recalled the products. Recently CFDA issued a circular calling for close cooperation and taking measures to ensure the recall.
CFDA will organize in-depth investigation, confirm the reason and responsibility and deal with the situation according to the law. The investigation situation will be announced to the public in time.March 17, 2015 at 12:16 am #667
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