21 CFR 1.393 - What information must FDA include in the detention order?

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§ 1.393 What information must FDA include in the detention order?
(a) FDA must issue the detention order in writing, in the form of a detention notice, signed and dated by the officer or qualified employee of FDA who has reason to believe that such article of food is adulterated or misbranded.
(b) The detention order must include the following information:
(1) The detention order number;
(2) The date and hour of the detention order;
(3) Identification of the detained article of food;
(4) The period of the detention;
(5) A statement that the article of food identified in the order is detained for the period shown;
(6) A brief, general statement of the reasons for the detention;
(7) The address and location where the article of food is to be detained and the appropriate storage conditions;
(8) Any applicable conditions of transportation of the detained article of food;
(9) A statement that the article of food is not to be consumed, moved, altered, or tampered with in any manner during the detention period, unless the detention order is first modified under § 1.381(c);
(10) The text of section 304(h) of the act and §§ 1.401 and 1.402;
(11) A statement that any informal hearing on an appeal of a detention order must be conducted as a regulatory hearing under part 16 of this chapter, with certain exceptions described in § 1.403;
(12) The mailing address, telephone number, e-mail address, and fax number of the FDA district office and the name of the FDA District Director in whose district the detained article of food is located;
(13) A statement indicating the manner in which approval of the detention order was obtained, i.e., verbally or in writing; and
(14) The name and the title of the authorized FDA representative who approved the detention order.
[69 FR 31701, June 4, 2004, as amended at 76 FR 25541, May 5, 2011]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-05-29; vol. 79 # 103 - Thursday, May 29, 2014
    1. 79 FR 30716 - Administrative Detention of Drugs Intended for Human or Animal Use
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective June 30, 2014.
      21 CFR Parts 1 and 16

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1 after this date.

  • 2014-09-29; vol. 79 # 188 - Monday, September 29, 2014
    1. 79 FR 58524 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; supplemental notice of proposed rulemaking.
      Submit either electronic or written comments on the proposed rule by December 15, 2014 Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 15, 2014 (see the “Paperwork Reduction Act of 1995” section of this document).
      21 CFR Parts 1, 16, and 117