Current through May 31, 2024
Section 111.127 - What quality control operations are required for packaging and labeling operations?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.