part_subject: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
subpart_code: "N"
subpart_subject: "Returned Dietary Supplements"
section_number: "111.535"
section_subject: "Under this subpart N, what records must you make and keep?"
cfr_reference: "21 CFR 111.535"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 100 to 169"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)You must make and keep records required under this subpart N in accordance with subpart P of this part.
(1)Written procedures for fulfilling the requirements of this subpart N.
(2)Any material review and disposition decision on a returned dietary supplement;
(3)The results of any testing or examination conducted to determine compliance with product specifications established under § 111.70(e); and,
(4)Documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications established in accordance with § 111.70(e).