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Reporter February 6 from the State Food and Drug Administration was informed that the same day the Bureau interviewed recently exposed injection quality problems of Shandong Qidu Pharmaceutical Co., Ltd., asked it to immediately carry out self-examination of the production management system, timely to the regulatory authorities to report on rectification. For the company after the incident to destroy the problem products, trying to cover up the facts of the violation, the bureau tasked the Shandong Provincial Food and Drug Administration to deal with in accordance with the law.
recently, a clinic in Changchun City, Jilin Province, found that Shandong Qidu Pharmaceutical Co., Ltd. produced hydrochloric acid left oxyfluorosa star sodium chloride injection has a hair-like foreign body. After the incident, the company's sales staff destroyed the products involved, but other evidence showed that there was indeed a quality problem with the products involved.
The State Administration of Food and Drug Administration pointed out that the company's clerks destroyed evidence and covered up the facts, seriously violated the basic requirements of the Code of Quality Management of Pharmaceutical Production, the nature of which is extremely bad, Shandong Province Food and Drug Administration must deal with the enterprise in accordance with the law. Shandong Qidu Pharmaceutical Co., Ltd. said it accepts the regulatory authorities' opinion and will immediately rectify and take full responsibility for the consequences.
it is known that Shandong Qidu Pharmaceutical Co., Ltd. produced the batch number of Sodium chloride injection of LOX fluorosa star is C13042201, a total of 21,700 bottles, April 22, 2013 Daily production, valid until the end of March 2015, the products are sold to Jilin Province (8000 bottles), Hebei Province (10,500 bottles), Heilongjiang Province (2300 bottles), Liaoning Province (900 bottles) 4 places. The State Administration of Food and Drug Administration has asked the drug regulatory departments of the above-mentioned provinces to pay attention to the circulation and use of the products involved and take strong measures to supervise the recall of products by enterprises, and to require the drug adverse reaction monitoring institutions to strengthen monitoring, detect adverse reactions and report them in a timely manner and dispose of them in accordance with the law.
The State Administration of Food and Drug Administration requires that all pharmaceutical manufacturers should learn from the incident, strict quality management, strict quality control of drugs, should correctly handle product quality issues, never allow concealment of facts, deceive the public. At the same time, the bureau reminded consumers, found suspected quality problems of drugs, should immediately call "12331" or log on to the "12331" website to complain to the drug regulatory authorities. (Health News)