Medical network on March 23 - March 20, the CFDA website (http://www.chemdrug.com/article/11/) on the stop imports Switzerland OM Pharma SA bacteria lysate capsule announcement said that the bacteria in Switzerland OM Pharma SA solute capsule (trade name: pan fu shu) production site inspection found that the variety of fermentation process, fermentation conditions change, change cracking step blending process change not in accordance with the measures for the administration of the drug (http://www.chemdrug.com/) registered annex 4 of the regulations, does not conform to article one hundred and eighty-four of the "drug production quality management norms" requirements; Violation of article 9 of the pharmaceutical administration law of the People's Republic of China, "drug registration management approach" the provisions of the second paragraph of article eighty-four.
CFDA decided to stop the Swiss OM Pharma SA bacteria to solute capsule imports, ask for each port of food and drug administration to stop the Swiss OM Pharma SA bacteria solute capsule of import customs clearance for the record.
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