CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (parts 100 to 191) > PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS > SUBPART F—Production and Process Control System: Requirements for Quality Control (§111.103 to §111.140) > 111.127—What quality control operations are required for packaging and labeling operations?

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.