16.0 - GMP Records for Supplements supplier approval identified through a sound statistical

identified through a sound statistical sampling plan (or otherwise every finished batch)

quality and purity is met

You must quarantine materials and dietary supplements you receive before you use them in the manufacture of a dietary supplement until you collect representative samples of each unique lot and Quality control personnel review and approve the results of any tests or examinations conducted

microbiological testing

16.0 - GMP Records for Supplements supplier approval identified through a sound statisticalYou must keep written records required by this part for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records. You must have all records required readily available during the retention period for inspection and copying by FDA when requested