21 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.