16.0 - GMP Records for Supplements supplier approval or hold components of dietary

or hold components of dietary supplements using approved chemical agents at the required frequency to prevent contamination

Any physical plant you use in the manufacture

microbiological testing

monitoring

16.0 - GMP Records for Supplements supplier approval or hold components of dietaryYou 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