§ 111.530. When must an investigation be conducted of your manufacturing processes and other batches?
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/us/cfr/t21/s§ 111.530·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
If the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of your manufacturing processes and each of those other batches to determine compliance with specifications.