21 C.F.R. § 111.127

What quality control operations are required for packaging and labeling operations?

Last amended: 2016Year: 2026Length: 179 wordsSubsections: 8Official source

Cite as 21 C.F.R. § 111.127 (2026)

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.
Cross-references to the CFR
111.70
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