褰撳墠浣嶇疆: 棣栭〉 » 鏀跨瓥娉曡 » 鍥藉娉曡 »搂107.260 瀵瑰┐鍎块厤鏂圭矇鍙洖鐨勪慨姝�(Revision of an infant formula recall)

搂107.260 瀵瑰┐鍎块厤鏂圭矇鍙洖鐨勪慨姝�(Revision of an infant formula recall)

鎵弿浜岀淮鐮� 鍒嗕韩濂藉弸鍜屾湅鍙嬪湀
鏀惧ぇ瀛椾綋  缂╁皬瀛椾綋 2011-08-21 09:55:44  鏉ユ簮锛欸PO  娴忚娆℃暟锛�2987
鏍稿績鎻愮ず锛氬湪瀵规墽琛屽彫鍥炵殑鍟嗚鍒跺畾鐨勫彫鍥炶鍒掓垨瀹氭湡鎶ュ憡鐨勫鏌ワ紝鎴栬€呭鍙洖宸ヤ綔鐩戝療涔嬪悗锛孎DA璁や负鍟嗚鐨勫彫鍥炲伐浣滀腑鏈変笉瓒充箣澶勶紝FDA鏈烘瀯灏嗕笉瓒充箣澶勯€氱煡鍟嗚銆傚彲瑕佹眰鍟嗚瀵笷DA寰楀埌鐨勮祫鏂欏仛鍑虹粨璁猴細瀵逛簬濠村効閰嶆柟绮夊浜轰綋鍋ュ悍鍗卞璁よ瘑涓嶈冻锛屽彫鍥炲伐浣滄繁搴︿笉澶燂紝鍒欒姹傛敼鍙樺彫鍥炶寖鍥淬€傚鏋淔DA鐨勫鏌ユ垨鍏朵粬璧勬枡琛ㄦ槑鍙洖娌℃湁鏈夋晥杩涜锛屽垯瑕佹眰澧炲姞鏈夋晥鎬ф鏌ャ€侳DA鐨勫鏌ユ樉绀哄厛鍓嶇殑閫氱煡娌℃湁鏀跺埌锛屽垯瑕佹眰鍟嗚瀵瑰畠鐨勭洿鎺ヨ仈绯诲鎴烽噸鍙戦€氱煡銆�
鍙戝竷鍗曚綅
FDA
FDA
鍙戝竷鏂囧彿 鏆傛棤
鍙戝竷鏃ユ湡 鏆傛棤 鐢熸晥鏃ユ湡 鏆傛棤
鏈夋晥鎬х姸鎬� 搴熸鏃ユ湡 鏆傛棤
澶囨敞 鍦ㄥ鎵ц鍙洖鐨勫晢琛屽埗瀹氱殑鍙洖璁″垝鎴栧畾鏈熸姤鍛婄殑瀹℃煡锛屾垨鑰呭鍙洖宸ヤ綔鐩戝療涔嬪悗锛孎DA璁や负鍟嗚鐨勫彫鍥炲伐浣滀腑鏈変笉瓒充箣澶勶紝FDA鏈烘瀯灏嗕笉瓒充箣澶勯€氱煡鍟嗚銆傚彲瑕佹眰鍟嗚瀵笷DA寰楀埌鐨勮祫鏂欏仛鍑虹粨璁猴細瀵逛簬濠村効閰嶆柟绮夊浜轰綋鍋ュ悍鍗卞璁よ瘑涓嶈冻锛屽彫鍥炲伐浣滄繁搴︿笉澶燂紝鍒欒姹傛敼鍙樺彫鍥炶寖鍥淬€傚鏋淔DA鐨勫鏌ユ垨鍏朵粬璧勬枡琛ㄦ槑鍙洖娌℃湁鏈夋晥杩涜锛屽垯瑕佹眰澧炲姞鏈夋晥鎬ф鏌ャ€侳DA鐨勫鏌ユ樉绀哄厛鍓嶇殑閫氱煡娌℃湁鏀跺埌锛屽垯瑕佹眰鍟嗚瀵瑰畠鐨勭洿鎺ヨ仈绯诲鎴烽噸鍙戦€氱煡銆�

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銆€銆€§ 107.260   Revision of an infant formula recall.

銆€銆€If after a review of the recalling firm's recall strategy or periodic reports or other monitoring of the recall, the Food and Drug Administration concludes that the actions of the recalling firm are deficient, the agency shall notify the recalling firm of any serious deficiency. The agency may require the firm to:

銆€銆€锛坅锛� Change the extent of the recall, if the agency concludes on the basis of available data that the depth of the recall is not adequate in light of the risk to human health presented by the infant formula.

銆€銆€锛坆锛� Carry out additional effectiveness checks, if the agency's audits, or other information, demonstrate that the recall has not been effective.

銆€銆€锛坈锛� Issue additional notifications to the firm's direct accounts, if the agency's audits, or other information demonstrate that the original notifications were not received, or were disregarded in a significant number of cases.

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 鏍囩锛� 閰嶆柟 妫€鏌� 鍙洖 
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