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§107.210 婴儿配方粉的厂家主动召回(Firm-initiated product removals)
2011-08-20 22:51  点击:3032
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:如果生产商自愿决定从市场上召回一批婴儿配方粉,其原因不是107.200中所述的,而是由于其他方面违反了法律和FDA的管理规定,并且可能引起法律纠纷,那么生产商必须立即通知FDA,同时自愿进行撤回。如果生产商自愿决定从市场上召回一批婴儿配方粉,但这些食品只是轻度的掺杂或标签错误,不会引起法律纠纷的,这种从市场上取走产品的行为被认为属于本章7.3(j)中规定的撤出市场行为。

       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

  § 107.210   Firm-initiated product removals.

  (a) If a manufacturer has determined to recall voluntarily from the market an infant formula that is not subject to §107.200 but that otherwise violates the laws and regulations administered by the Food and Drug Administration (FDA) and that would be subject to legal action, the manufacturer, upon prompt notification to FDA, shall administer such voluntary recall consistent with the requirements of this subpart.

  (b) If a manufacturer has determined to withdraw voluntarily from the market an infant formula that is adulterated or misbranded in only a minor way and that would not be subject to legal action, such removal from the market is deemed to be a market withdrawal, as defined in §7.3(j) of this chapter. As required by §107.240(a), the manufacturer shall promptly notify FDA of such violative formula and may, but is not required to, conduct such market withdrawal consistent with the requirements of this subpart pertaining to product recalls.

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下一篇:§107.230 婴儿配方粉的召回注意事项(Elements of an infant formula recall)
上一篇:§107.200 FDA对婴儿配方粉的召回(Food and Drug Administration-required recall)