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

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Quality control operations for returned dietary supplements must include:

Conducting any required material review and making any required disposition decision; including:

Determining whether tests or examination are necessary to determine compliance with product specifications established in accordance with § 111.70(e); and

Reviewing the results of any tests or examinations that are conducted to determine compliance with product specifications established in accordance with § 111.70(e);

Approving or rejecting any salvage and redistribution of any returned dietary supplement;

Approving or rejecting any reprocessing of any returned dietary supplement; and

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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