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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) > 111.130—What quality control operations are required for returned dietary supplements?

CFR

111.130—What quality control operations are required for returned dietary supplements?

Quality control operations for returned dietary supplements must include:
(a) Conducting any required material review and making any required disposition decision; including:
(1) Determining whether tests or examination are necessary to determine compliance with product specifications established in accordance with § 111.70(e); and
(2) Reviewing the results of any tests or examinations that are conducted to determine compliance with product specifications established in accordance with § 111.70(e) ;
(b) Approving or rejecting any salvage and redistribution of any returned dietary supplement;
(c) Approving or rejecting any reprocessing of any returned dietary supplement; and
(d) Determining whether the reprocessed dietary supplement meets product specifications and either approving for release, or rejecting, any returned dietary supplement that is reprocessed.
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