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21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
72 FR 34942, June 25, 2007, unless otherwise noted.
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(a) Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and
(b) The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel.