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§107.260 对婴儿配方粉召回的修正(Revision of an infant formula recall)
2011-08-21 09:55  点击:2977
发布单位:FDA
发布文号:暂无
发布日期:暂无
生效日期:暂无
有效性状态:
废止日期:暂无
备注:在对执行召回的商行制定的召回计划或定期报告的审查,或者对召回工作监察之后,FDA认为商行的召回工作中有不足之处,FDA机构将不足之处通知商行。可要求商行对FDA得到的资料做出结论:对于婴儿配方粉对人体健康危害认识不足,召回工作深度不够,则要求改变召回范围。如果FDA的审查或其他资料表明召回没有有效进行,则要求增加有效性检查。FDA的审查显示先前的通知没有收到,则要求商行对它的直接联系客户重发通知。

       更多关于婴儿配方粉的法规,请详见美国FDA 21 CFR 第107部分关于婴儿配方粉的法规汇总

  § 107.260   Revision of an infant formula recall.

  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:

  (a) 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.

  (b) Carry out additional effectiveness checks, if the agency's audits, or other information, demonstrate that the recall has not been effective.

  (c) 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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下一篇:§107.270 本分部婴儿配方粉召回需遵循的要求(Compliance with this subpart)
上一篇:§107.250 婴儿配方粉召回工作的终止(Termination of an infant formula recall)
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