§111.127. What quality control operations are required for packaging and labeling operations?
21 C.F.R. § 111.127
Quality control operations for packaging and labeling operations must include:
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);
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;
Reviewing and approving all records for packaging and label operations;
Determining whether the finished packaged and labeled dietary supplement conforms to specifications established in accordance with § 111.70(g);
Conducting any required material review and making any required disposition decision;
Approving or rejecting any repackaging of a packaged dietary supplement;
Approving or rejecting any relabeling of a packaged and labeled dietary supplement; and
Approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
Source
Source: 72 FR 34942, June 25, 2007, unless otherwise noted.