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§108.10 许可证的暂时吊销和恢复(Suspension and reinstatement of permit)
2011-08-21 11:20  点击:2694
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:每当专员发现许可证持有人违反了该许可证所规定的强制性条件和要求,他必须立即暂停使用许可证并将此决定及暂停理由通知许可证持有人。在收到恢复许可证的申请后10个工作日内,专员如果查明该持有人遵守了该许可证规定的强制性条件和要求,他必须恢复许可证,反之则拒绝申请。许可证被暂停使用的人或申请恢复许可证被拒绝的人可以请求举行听证会。在听证会后5个工作日内,决定是否恢复许可证。

      更多关于食品安全许可证的法规,请详见 美国FDA 21 CFR 第108部分关于食品安全许可证管理的法规汇总

  § 108.10   Suspension and reinstatement of permit.

  (a) Whenever the Commissioner finds that a permit holder is not in compliance with the mandatory requirements and conditions established by the permit, he shall immediately suspend the permit and so inform the permit holder, with the reasons for the suspension.

  (b) Upon application for reinstatement of a permit, the Commissioner shall, within 10 working days, reinstate the permit if he finds that the person is in compliance with the mandatory requirements and conditions established by the permit or deny the application.

  (c) Any person whose permit has been suspended or whose application for reinstatement has been denied may request a hearing. The hearing shall be conducted by the Commissioner or his designee within 5 working days of receipt of the request at a location agreed upon by the objector and the Commissioner or, if an agreement cannot be reached, at a location designated by the Commissioner. The permit holder shall have the right to present witnesses on his own behalf and to cross-examine the Food and Drug Administration's witnesses.

  (d) Within 5 working days after the hearing, and based on the evidence presented at the hearing, the Commissioner shall determine whether the permit shall be reinstated and shall so inform the permit holder, with the reasons for his decision.

  (e) Denial of an application for reinstatement of a permit constitutes final agency action from which appeal lies to the courts. The Commisioner will not stay such denial pending court appeal except in unusual circumstances, but will participate in expediting any such appeal.

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下一篇:§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)
上一篇:§108.6 需要安全许可证决定的撤销(Revocation of determination of need for permit)