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Code · CFR · Title 21 — Food and Drugs · Part 1003 — Notification of Defects or Failure to Comply · § 1003.20

§ 1003.20. Notification by the manufacturer to the Secretary.

168 words·~1 min read·/us/cfr/t21/s§ 1003.20·

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The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:
(a)Identification of the product or products involved;
(b)The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;
(c)The expected usage for the product if known to the manufacturer;
(d)A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard;
(e)An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard;
(f)A statement of the measures to be taken to repair such defect or to bring the product into compliance with the Federal standard;
(g)The date and circumstances under which the defect was discovered; and
(h)The identification of any trade secret information which the manufacturer desires kept confidential.
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