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§108.12 无证或违反许可证的制造、加工或包装(Manufacturing, processing, or packing without a permit, or in violation of a permit)

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放大字体缩小字体2011-08-21 11:30:04 来源:GPO 浏览次数9span id="hits">2661
核心提示:专员已经做出判定属于需要具备许可证的食品,其制造商、加工商或包装商仍可在没有许可证的情况下,由他自己承担风险和责任,继续进行食品制造、加工或包装。所有在没有许可证期间制造、加工和包装的食品必须留存,在没有FDA授予的事先书面批准前不得推出或交付州际贸易。凡是在无证或违反许可证情况下制造的商品,均不得进行州际贸易、/div>
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FDA
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备注 专员已经做出判定属于需要具备许可证的食品,其制造商、加工商或包装商仍可在没有许可证的情况下,由他自己承担风险和责任,继续进行食品制造、加工或包装。所有在没有许可证期间制造、加工和包装的食品必须留存,在没有FDA授予的事先书面批准前不得推出或交付州际贸易。凡是在无证或违反许可证情况下制造的商品,均不得进行州际贸易、/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 />
   108.12 Manufacturing, processing, or packing without a permit, or in violation of a permit.

  (a A manufacturer, processor, or packer may continue at his own risk to manufacture, process, or pack without a permit a food for which the Commissioner has determined that a permit is required. All food so manufactured, processed, or packed during such period without a permit shall be retained by the manufacturer, processor, or packer and may not be introduced or delivered for introduction into interstate commerce without the advance written approval of the Food and Drug Administration. Such approval may be granted only upon an adequate showing that such food is free from microorganisms of public health significance. The manufacturer, processor, or packer may provide to the Commissioner, for his consideration in making any such determination, an evaluation of the potential public health significance of such food by a competent authority in accordance with procedures recognized as being adequate to detect any potential hazard to public health. Within 20 working days after receipt of a written request for such written approval the Food and Drug Administration shall either issue such written approval or deny the request. If the request is denied, the applicant shall, upon request, be afforded a prompt hearing conducted in accordance with 108.5 (b and (c?

  (b Except as provided in paragraph (a of this section, no manufacturer, processor, or packer may introduce or deliver for introduction into interstate commerce without a permit or in violation of a permit a food for which the Commissioner has determined that a permit is required. Where a manufacturer, processor, or packer utilizes a consolidation warehouse or other storage facility under his control, interstate shipment of any such food from the point of production to that warehouse or storage facility shall not violate this paragraph, provided that no further introduction or delivery for introduction into interstate commerce is made from that consolidated warehouse or storage facility except as provided in paragraph (a of this section.

地区9/font>美国
标签9/font>许可?nbsp;风险包装
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