part_subject: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
subpart_code: "F"
subpart_subject: "Production and Process Control System: Requirements for Quality Control"
section_number: "111.127"
section_subject: "What quality control operations are required for packaging and labeling operations?"
cfr_reference: "21 CFR 111.127"
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"
---
Quality control operations for packaging and labeling operations must include:
(a)Reviewing the results of any visual examination and documentation to ensure that specifications established under § 111.70(f) are met for all products that you receive for packaging and labeling as a dietary supplement (and for distribution rather than for return to the supplier);
(b)Approving, and releasing from quarantine, all products that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) before they are used for packaging or labeling;
(c)Reviewing and approving all records for packaging and label operations;
(d)Determining whether the finished packaged and labeled dietary supplement conforms to specifications established in accordance with § 111.70(g);
(e)Conducting any required material review and making any required disposition decision;
(f)Approving or rejecting any repackaging of a packaged dietary supplement;
(g)Approving or rejecting any relabeling of a packaged and labeled dietary supplement; and
(h)Approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution.