Regarding the “hair” alike visible particles in Levofloxacin Hydrochloride and Sodium Chloride Injection produced by Shandong Qidu Pharmaceutical Co., Ltd., the local CFDA, Food and Drug Administration Zibo City, has measured out a severe punishment and ordered Shandong Qidu Pharmaceutical Co., Ltd. to suspend business for internal rectification, after the on-site inspection.
The measures taken were as follows: First, the company was required to recall all batches of related products. As of February 12, 2015, the company has completed the recall; Second, a fine of three times of those batches of drugs’ sales income was imposed; Third, the company needs to suspend its production, to find potential risks in depth, analyze the problem occurred and management loopholes to prevent similar problems; Fourth, make sure the implementation and operation of quality assurance system to ensure the quality and safety of the pharmaceutical production.
Previously on: CFDA investigated visible particles for Injection of Shandong Qidu Pharmaceutical
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