{"id":43671,"date":"2016-05-02T17:46:34","date_gmt":"2016-05-02T21:46:34","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-imports\/alerts\/"},"modified":"2020-07-14T14:27:18","modified_gmt":"2020-07-14T14:27:18","slug":"alerts","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/jp\/fda-imports\/alerts\/","title":{"rendered":"FDA\u8f38\u5165\u8b66\u544a\uff1a\u30ec\u30c3\u30c9\u30ea\u30b9\u30c8\u3068\u30b0\u30ea\u30fc\u30f3\u30ea\u30b9\u30c8"},"content":{"rendered":"<div 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\/>\n<p><strong>FDA\u3078\u306e\u8f38\u5165\u8b66\u544a\u306e\u514d\u9664\u7533\u8acb\uff08\u30ec\u30c3\u30c9\u30ea\u30b9\u30c8\u304b\u3089\u306e\u524a\u9664\u307e\u305f\u306f\u30b0\u30ea\u30fc\u30f3\u30ea\u30b9\u30c8\u3078\u306e\u8ffd\u52a0\uff09<\/strong><\/p>\n<p>\u30b0\u30ea\u30fc\u30f3\u30ea\u30b9\u30c8\u306f\u3001\u7279\u5b9a\u306e\u56fd\u5168\u4f53\u306e\u8f38\u5165\u8b66\u544a\u3092\u514d\u9664\u3055\u308c\u308b\u4f01\u696d\u306e\u30ea\u30b9\u30c8\u3067\u3059\u3002\u4e0a\u8a18\u306e\u4f8b\u306b\u5f93\u3063\u3066\u3001\u30b0\u30ea\u30fc\u30f3\u30ea\u30b9\u30c8\u306b\u542b\u307e\u308c\u3066\u3044\u308b\u30a4\u30f3\u30c9\u306e\u4f01\u696d\u306b\u3088\u3063\u3066\u8f38\u51fa\u3055\u308c\u305f\u30a8\u30d3\u306f\u3001DWPE\u306e\u5bfe\u8c61\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<ul>\n<li>An analysis by your firm of the violation that caused FDA to issue the Import Alert, as well determining the corrective actions or preventive measures your firm must undertake in response.<\/li>\n<li>Once your corrective actions have been implemented, FDA will require evidence that these actions were successful in resolving the issue, including (but not limited to) proof of five to twelve cleared, non-violative shipments of the product to the United States. Registrar Corp can assist with the detentions of these shipments and in obtaining and properly organizing the necessary documentation.<\/li>\n<li>Upon completion of steps 1 and 2 above, evidence must be gathered and organized into a petition to be submitted and reviewed by FDA&#8217;s Division of Import Operations.<\/li>\n<\/ul>\n<p>FDA\u306b\u3088\u308b\u3068\u30012013\u5e74\u306bFDA\u306e\u8f38\u5165\u8b66\u544a\u30ec\u30c3\u30c9\u30ea\u30b9\u30c8\u306b\u63b2\u8f09\u3055\u308c\u305f\u7d0413,000\u793e\u306e3\uff05\u672a\u6e80\u304c\u524a\u9664\u3092\u7533\u8acb\u3057\u3001\u30b0\u30ea\u30fc\u30f3\u30ea\u30b9\u30c8\u3078\u306e\u8ffd\u52a0\u304c\u3092\u7533\u8acb\u3057\u305f\u306e\u306f165\u793e\u306e\u307f\u3067\u3059\u3002 \u591a\u304f\u306f\u8acb\u9858\u306e\u5927\u5909\u3055\u306b\u8170\u304c\u5f15\u3051\u3066\u3044\u307e\u3059\u3002 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