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§108.7 签发或拒绝签发安全许可证(Issuance or denial of permit)

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放大字体缩小字体2011-08-21 10:54:54 来源:GPO 浏览次数9span id="hits">3219
核心提示:当专员按照108.5的规定做出了决定并通知食品制造商、加工商或包装商必须持有许可证后,在他们获得专员签发的许可证?08.12(a)规定的FDA的预先书面批准书前,这些食品制造商、加工商或包装商不得把有其制造、加工或包装的食品投入州际贸易。已确定需要许可证的食品制造商、加工商或包装商可申请签发这一许可证,申请要包含必要的数据和资料。专员拒绝给予许可证的决定构成管理机构的最终行为的可以上诉、/div>
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备注 当专员按?08.5的规定做出了决定并通知食品制造商、加工商或包装商必须持有许可证后,在他们获得专员签发的许可证?08.12(a)规定的FDA的预先书面批准书前,这些食品制造商、加工商或包装商不得把有其制造、加工或包装的食品投入州际贸易。已确定需要许可证的食品制造商、加工商或包装商可申请签发这一许可证,申请要包含必要的数据和资料。专员拒绝给予许可证的决定构成管理机构的最终行为的可以上诉、/td>

更多关于食品安全许可证的法规,请详见美国FDA 21 CFR ?08部分关于食品安全许可证管理的法规汇怺/font>、br />
   108.7 Issuance or denial of permit.

  (a After a determination and notification by the Commissioner in accordance with the provisions of 108.5 that a manufacturer, processor, or packer requires a permit, such manufacturer, processor, or packer may not thereafter introduce or deliver for introduction into interstate commerce any such food manufactured, processed, or packed by him unless he holds a permit issued by the Commissioner or obtains advance written approval of the Food and Drug Administration pursuant to 108.12(a?

  (b Any manufacturer, processor, or packer for whom the Commissioner has made a determination that a permit is necessary may apply to the Commissioner for the issuance of such a permit. The application shall contain such data and information as is necessary to show that all mandatory requirements and conditions for the manufacturer, processing or packing of a food for which regulations are established in subpart B of this part are met and, in particular, shall show that the deviations specified in the Commissioner's determination of the need for a permit have been corrected or suitable interim measures established. Within 10 working days after receipt of such application, (except that the Commissioner may extend such time an additional 10 working days where necessary? the Commissioner shall issue a permit, deny the permit, or offer the applicant a hearing conducted in accordance with 108.5 (b and (c as to whether the permit should be issued. The Commissioner shall issue such a permit to which shall be attached, in addition to the mandatory requirements and conditions of subpart B of this part, any additional requirements or conditions which may be necessary to protect the public health if he finds that all mandatory requirements and conditions of subpart B of this part are met or suitable interim measures are established.

  (c Denial of a permit constitutes final agency action from which appeal lies to the courts. The Commissioner will not stay such denial pending court appeal except in unusual circumstances, but will participate in expediting any such appeal.

地区9/font>美国
标签9/font>安全许可?nbsp;许可?nbsp;包装
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