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§107.210 嬰兒配方粉的廠家主動召回(Firm-initiated product removals)

   2011-08-20 610
核心提示:更多關于嬰兒配方粉的法規,請詳見美國FDA 21 CFR 第107部分關于嬰兒配方粉的法規匯總。   107.210 Firm-initiated product r

       更多關于嬰兒配方粉的法規,請詳見美國FDA 21 CFR 第107部分關于嬰兒配方粉的法規匯總

  § 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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