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§80.34 拒绝认证服务的授权(Authority to refuse certification service)

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放大字体  缩小字体 2011-09-15 11:53:30  来源:GPO  浏览次数:3204
核心提示:有人通过欺骗或者误导已经获得或试图获得认证或者在§80.39规定的记录中掺假或者没有记录或者拒绝允许食品药品管理局正式授权的人员自由接触所有生产设备,工艺和着色剂生产配方和来源,存在以上情况之一的,受理专员均会中止其认证服务直至其申请行为合格,被中止认证的人员有机会参加法规听证。
发布单位
FDA
FDA
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备注 有人通过欺骗或者误导已经获得或试图获得认证或者在§80.39规定的记录中掺假或者没有记录或者拒绝允许食品药品管理局正式授权的人员自由接触所有生产设备,工艺和着色剂生产配方和来源,存在以上情况之一的,受理专员均会中止其认证服务直至其申请行为合格,被中止认证的人员有机会参加法规听证。

  § 80.34   Authority to refuse certification service.

  (a) When it appears to the Commissioner that a person has:

  (1) Obtained, or attempted to obtain, a certificate through fraud or misrepresentation of a material fact.

  (2) Falsified the records required to be kept by §80.39; or

  (3) Failed to keep such records, or to make them available, or to accord full opportunity to make inventory of stocks on hand or otherwise to check the correctness of such records, as required by §80.39; or

  (4) Refused to permit duly authorized employees of the Food and Drug Administration free access to all manufacturing facilities, processes, and formulae involved in the manufacture of color additives and intermediates from which such color additives are derived; he may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken.

  (b) Any person who contests suspension of service shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.

 

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