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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) > 111.120—What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?

CFR

111.120—What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?

Quality control operations for components, packaging, and labels before use in the manufacture of a dietary supplement must include:
(a) Reviewing all receiving records for components, packaging, and labels;
(b) Determining whether all components, packaging, and labels conform to specifications established under § 111.70 (b) and (d) ;
(c) Conducting any required material review and making any required disposition decision;
(d) Approving or rejecting any treatment and in-process adjustments of components, packaging, or labels to make them suitable for use in the manufacture of a dietary supplement; and
(e) Approving, and releasing from quarantine, all components, packaging, and labels before they are used.
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